MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC EXTENDER-6MM HXC; SCREWDRIVERS

Catalog Number	03.611.059
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).A review of the device history records has been requested.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, during the spinal fusion procedure the surgeon was using the spine screw removal set to remove a broken unknown screw.The surgeon was using the ratchet t-handle with extender and had difficulty connecting the two instruments.Once connected, the surgeon was able to successfully remove the broken unknown screw, but the two instruments would not come apart after and the hospital employee wasn't able to disconnect the instruments upon inspection.The surgeon attempted to remove unknown screws without the extender that was connected to ratchet t-handle, he then tried to connect extender to ratchet t-handle until they connected.The procedure was successfully completed with a surgical delay of three-five (3-5) minutes.Patient outcome was unknown.Concomitant device reported: unknown screws (part# unknown, lot# unknown, quantity unknown).This complaint involves one (1) devices.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Visual inspection of the returned device performed at customer quality (cq) identified minor surface wear but no damage that would inhibit functionality was observed.Functional testing relevant to this complaint was not possible since the two devices were received assembled and could not be dis-assembled and re-assembled.The complaint could not be replicated since the two devices were received assembled and could not be dis-assembled and re-assembled.Dimensional inspection relevant to this complaint could not be performed since the relevant features are not accessible.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.A definitive root cause for the reported condition could not be determined based on the provided information.The reported complaint, unable to disassemble was confirmed.No product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.No new, unique or different patient harms were identified as a result of this evaluation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot: part # 03.611.059.Synthes lot # 6596151.Supplier lot # 6596151.Release to warehouse date: 04 may 2011.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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
Concomitant device reported: unknown rod(part# unknown, lot# unknown, quantity unknown).

• Brand Name: EXTENDER-6MM HXC
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8525091
• Report Number: 2939274-2019-57539
• Device Sequence Number: 2869213
• Product Code: HXX
• UDI-Device Identifier: 07611819824034
• UDI-Public: (01)07611819824034
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/25/2019

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 Catalogue Number: 03.611.059
• Device Lot Number: 6596151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2019
• Initial Date Received by Manufacturer: 03/25/2019
• Supplement Date Received by Manufacturer: 05/08/2019; 05/30/2019
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 05/29/2019; 06/18/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - RODS.