MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SHAFT FOR TREPHINE ATTACHMENTS

Model Number	03.111.030
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: reporter is a synthes employee.Part: 03.111.030, lot: 9858451, manufacturing site: (b)(4), release to warehouse date: may 31, 2016.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the shaft for trephine attachments was received at us customer quality (cq).One of the distal prongs of the device was broken.No fragments were returned.The received condition was consistent with the complaint condition thus the complaint was confirmed.Dimensional inspection: dimensional analysis was not performed as relevant parts/features were not returned and due to post-manufacturing damage.Conclusion: the overall complaint was confirmed for the received shaft for trephine attachments as one of the prongs was broken.Although no definitive root-cause can be determined, it is possible the device encountered unexpected forces during use.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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 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.
Event or Problem Description
It was reported that during a procedure on (b)(6) 2020, the bone harvesting instrumentation was not performing properly.The surgeon noticed that the connecting shaft would not hold the reamer heads well enough to extract bone graft without disconnecting the reamer head from the shaft itself.After a few tries, one of the two prongs that connect the trephine to the shaft broke off, rendering the bone harvesting instrumentation un-usable.However, enough bone graft was obtained to complete the case before this happened.Procedure was completed successfully with no delay.There was no patient consequence.This report is for a shaft for trephine attachments.This is report 1 of 1 for (b)(4).

• Brand Name: SHAFT FOR TREPHINE ATTACHMENTS
• Common Device Name: TREPHINE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10824148
• Report Number: 2939274-2020-05115
• Device Sequence Number: 3570276
• Product Code: HWK
• UDI-Device Identifier: 10886982072283
• UDI-Public: (01)10886982072283
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 03.111.030
• Device Catalogue Number: 03.111.030
• Device Lot Number: 9858451
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2020
• Initial Report FDA Received Date: 11/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1