MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-17 for TRAY, SUGRICAL manufactured by Synthes Usa.
[93583242]
This report is for unknown unk cab 1 set/unknown lot number. Device is an instrument and is not implanted/explanted. Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received. Concomitant device: unk cab 1 set. Unknown which passers caused the issue: 1x 391. 103 / lot p050587 (cable passer, medium, curved), 1x 391. 108 / lot p076240 (cable passer, large, 45? Angle), 1x 391. 104 / p076239 (cable passer, large, curved), 1x 391. 105 / p063554 (cable passer, medium), 1x 391. 106 / p076016 (cable passer, medium, 45? Angle), 1x 391. 107 / p078759 (cable passer, large). Device history records review was conducted for the following concomitant devices: part number: 391. 103 synthes lot number: p050587 supplier lot number: (b)(4) release to warehouse date: 24-apr-2009 supplier: (b)(4) dhr review part number: 391. 108 synthes lot number: p076240 supplier lot number: (b)(4) release to warehouse date: 14-jul-2010 supplier: (b)(4) dhr review part number: 391. 104 synthes lot number: p076239 supplier lot number: (b)(4) release to warehouse date: 28-jul-2010 supplier: (b)(4) dhr review part number: 391. 105 synthes lot number: p063554 supplier lot number: (b)(4) release to warehouse date: 07-jan-2010 supplier: (b)(4) dhr review part number: 391. 106 synthes lot number: p076016 supplier lot number: (b)(4) release to warehouse date: 08-jun-2010 supplier: (b)(4) dhr review part number: 391. 107 synthes lot number: p078759 supplier lot number: (b)(4) release to warehouse date: 04-aug-2010 supplier: (b)(4) no ncrs were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of this products, and any subcomponents, which would contribute to this complaint condition. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[93583243]
Device report from synthes on an event in (b)(6) as follows: when the reported cab-1 (the name of the surgical tool set assorted in (b)(6)) was about being washed postoperatively, it was found that some brown-colored liquid was leaking from the passer handles. It was uncertain which passer(s) had caused the issue. The devices in question were not used for the patient. This complaint involves 1 part. Concomitant device: 1x 391. 103 / lot p050587 (cable passer, medium, curved), 1x 391. 108 / lot p076240 (cable passer, large, 45? Angle), 1x 391. 104 / p076239 (cable passer, large, curved), 1x 391. 105 / p063554 (cable passer, medium), 1x 391. 106 / p076016 (cable passer, medium, 45? Angle), 1x 391. 107 / p078759 (cable passer, large). This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[122222172]
Six (6) additional parts added to complaint. Product development investigation was completed. The investigation summary indicates that the:1x 391. 103/lot p050587 (cable passer, medium, curved). The visual inspection has shown that signs of brown residues could be found inside the pouches. During the investigation, the device history for the returned parts was reviewed. No ncrs were generated during production. As the complaint points towards the brown residues, no, measurements, no hardening and no further tests were provided. Conclusion: no manufacturing related deviation could be found. As a possible root cause, it is likely that the provided washing and decontamination cycles might have not been repeated often enough to obtain clean instruments. Visual examination provided by chu. Dhr-review; no findings. Device used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[122222173]
Update 16jan. 2018: complaint re-opened for 6 parts added. This report is 1 of 7 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2520274-2017-12664 |
| MDR Report Key | 7041667 |
| Date Received | 2017-11-17 |
| Date of Report | 2017-10-25 |
| Date Mfgr Received | 2018-01-16 |
| Date Added to Maude | 2017-11-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | TRAY, SUGRICAL |
| Product Code | LRP |
| Date Received | 2017-11-17 |
| Returned To Mfg | 2017-11-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES USA |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-17 |