MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2015-08-14 for SELF-CAPTURE, SUTURE PASSER TRUEPASS 72203791 manufactured by Smith & Nephew, Inc..
[23062331]
One truepass suture passer, self-capture device and intact truepass needle, single pack, sterile needles from the same box as the broken needles were returned. The device was inspected visually for damage that could have contributed to the failure. None was found, though wear was observed at the exit point of the volcano which could indicate the device had been dry-fired significantly. Measurement of the unused needles returned with the device found all dimensions inspected to be within specification. The two returned needles were then also used to pass sutures through synthetic rotator cuff 20 times each without any failure. At this point no root cause for the observed failures can be identified. A review of the device history records was performed which confirmed no inconsistencies. No other complaint for the trupass device lot on file. The needles batch lot was not provided. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[23062332]
It was reported that during a rotator cuff repair, when passing suture, the needle tip broke. Trupass needles broke at the notch during the case. It was confirmed that all pieces were removed from the patient. There was a two hour procedural delay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219602-2015-00804 |
| MDR Report Key | 5004903 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2015-08-14 |
| Date of Report | 2014-05-16 |
| Date of Event | 2014-05-16 |
| Date Mfgr Received | 2014-05-23 |
| Device Manufacturer Date | 2013-12-31 |
| Date Added to Maude | 2015-08-14 |
| 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 | JAMES GONZALES |
| Manufacturer Street | 150 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 5123585706 |
| Manufacturer G1 | SMITH & NEPHEW, INC. |
| Manufacturer Street | 130 FORBES BOULEVARD |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02048 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SELF-CAPTURE, SUTURE PASSER TRUEPASS |
| Generic Name | WIRE/LIGATURE PASSER |
| Product Code | MIB |
| Date Received | 2015-08-14 |
| Returned To Mfg | 2014-06-06 |
| Catalog Number | 72203791 |
| Lot Number | 20821 |
| ID Number | 20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | 130 FORBES BOULEVARD MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-08-14 |