MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-26 for 6.0MM/10.0MM STEPPED DRILL BIT CANNULATED/LARGE QC/435MM 357.403 manufactured by Wrights Lane Synthes Usa Products Llc.
[185918722]
Reporter is company representative investigation summary visual inspection: the device was received and inspected. It was noticed that the device's distal tip was broken off. The complaint is confirmed. The broken piece was not returned. Dimension inspection: it was not performed due to post manufacturing damage and broken piece was not returned. Conclusion: the complaint is confirmed. It is possible that the device encountered unintended forces (during usage or handling at the time of surgery). During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition. Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed. Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities. Device history part # 357. 403, synthes lot # u333012, supplier lot # u333012, release to warehouse date: 15 nov 2019, supplier: orchid unique, no ncr's were generated during production. Device was 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
[185918723]
It was reported that on february 27, 2020, the patient underwent an unknown procedure. During reaming at the right femur to collect bone graft, the reamer head broke. The reamer head was removed with a guide wire but there were some fragments retained in the femur. There was an attempt to suction out the fragments but that failed. The guide wire was bent in an extreme curve to preferentially ream and collect ria graft from distal femur. The surgeon forced the ria reamer down over the bend of the wire and broke the reamer head. Fragments of the reamer head were left in the femur. The reamer head was removed via the ball tip guide wire. During opening the entry hole, the tip of a stepped cannulated drill bit broke. It is unknown if there was a surgical delay. The procedure was successfully completed. The patient's status is unknown. Concomitant device reported: guide wire (part# 351. 706s, lot# unknown, quantity# 1). This is report 1 of 2 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-01532 |
| MDR Report Key | 9882426 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-26 |
| Date of Report | 2020-02-27 |
| Date of Event | 2020-02-27 |
| Date Mfgr Received | 2020-02-27 |
| Device Manufacturer Date | 2019-11-15 |
| Date Added to Maude | 2020-03-26 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | MONUMENT |
| Manufacturer Street | 1101 SYNTHES AVENUE |
| Manufacturer City | MONUMENT CO 80132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 6.0MM/10.0MM STEPPED DRILL BIT CANNULATED/LARGE QC/435MM |
| Generic Name | REAMER |
| Product Code | HTO |
| Date Received | 2020-03-26 |
| Returned To Mfg | 2020-03-16 |
| Model Number | 357.403 |
| Catalog Number | 357.403 |
| Lot Number | U333012 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WRIGHTS LANE SYNTHES USA PRODUCTS LLC |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-26 |