MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-07 for SYNFRAME LENGTHENER 387.338 manufactured by Synthes Hagendorf.
[33019834]
It is unknown whether or not the issue occurred during a surgical procedure. Therefore, patient involvement cannot be confirmed. Device product code xxx used to report unavailable code fqp (lamp, operating room). Device is an instrument and is not implanted or explanted. Per facility, the complainant part was discarded and is not available for evaluation. The investigation could not be completed; no conclusion could be drawn as no product was received. Device history record review: manufacturing location: (b)(4) - manufacturing date: august 5, 1999. No non-conformance reports were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. 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
[33019835]
It was reported that a synframe lengthener instrument is missing screws. The reporting facility has no additional information pertaining to this event. Patient and/or surgical involvement is unknown. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003875359-2015-10516 |
| MDR Report Key | 5270548 |
| Date Received | 2015-12-07 |
| Date of Report | 2015-11-16 |
| Date Mfgr Received | 2015-11-16 |
| Device Manufacturer Date | 1999-08-05 |
| Date Added to Maude | 2015-12-07 |
| 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 | LINDA PLEWS |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | SYNTHES HAGENDORF |
| Manufacturer Street | IM BIFANG 6 |
| Manufacturer City | HAGENDORF CH4614 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH4614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SYNFRAME LENGTHENER |
| Generic Name | LAMP, OPERATING ROOM |
| Product Code | FQP |
| Date Received | 2015-12-07 |
| Catalog Number | 387.338 |
| Lot Number | 1038600 |
| ID Number | (01)10705034771076(10)1038600 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES HAGENDORF |
| Manufacturer Address | IM BIFANG 6 HAGENDORF CH4614 SZ CH4614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-12-07 |