MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11.0MM/8.0MM PROTECTION SLEEVE 188MM FOR ASLS; MISC ORTHO SURGICAL INSTR

Model Number	03.025.040
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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.Reporter is synthes sales consultant.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 while checking the alignment of protection sleeve for distal locking screw on short proximal femoral nailing system (tfna) nail it was noticed that it wasn¿t lining up correctly with the nail.There was no patient consequence.Concomitant device reported: locking screw (part# unknown, lot# unknown, quantity 1); 130 deg aiming arm (part # 03.037.013, lot# unknown, quantity 1); complete radiolucent insertion handle (part # 03.037.012, lot # unknown, quantity 1); tfna nail (part# unknown, lot# unknown, quantity 1).This report is for one (1) 11.0mm/8.0mm protection sleeve 188mm for asls.This is report 3 of 4 for complaint (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: the 11.0mm/8.0mm protection sleeve 188mm for asls (part # 03.025.040 / lot # l276521) was received at us cq.The device was received in good condition and there were no visual defects to note.Functional test: functional testing was performed with the returned 3 devices: complete radiolucent insertion handle (part # 03.037.012/ lot # l069567), 130 deg aiming arm (part # 03.037.013 / lot # l507393) and 11.0mm/8.0mm protection sleeve 188mm for asls (part # 03.025.040 / lot # l276521).The three devices assembled with no issue.There was no indication that the devices were misaligned.Since the relevant mating tfna nail was not returned, the misalignment issue was not able to be replicated.The overall complaint was not confirmed.Can the complaint be replicated with the returned device(s)? no, the issue could not be replicated since the relevant mating nail was not returned.There were no indications of a misalignment after assembling the returned devices.Dimensional inspection: dimensional inspection was not performed as no defect could be identified with the returned products.Document/specification review: drawing(s) reviewed: (current & manufactured revisions) conclusion: the overall complaint was not confirmed for the received 11.0mm/8.0mm protection sleeve 188mm for asls as no defect could be identified.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 history part: 03.025.040, lot: l276521, manufacturing site: hägendorf, release to warehouse date: 16.March 2017.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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 devices reported: unknown locking screw (part# unknown, lot# unknown, quantity 1), pedicle access cannula shaft (part# 03.632.322, lot# 7011915, quantity 1).
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.

• Brand Name: 11.0MM/8.0MM PROTECTION SLEEVE 188MM FOR ASLS
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10025980
• Report Number: 2939274-2020-02249
• Device Sequence Number: 16923228
• Product Code: LXH
• UDI-Device Identifier: 10886982069900
• UDI-Public: (01)10886982069900
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup,Followup
• Report Date (Section B): 04/22/2020

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: 03.025.040
• Device Catalogue Number: 03.025.040
• Device Lot Number: L276521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2020
• Initial Date Received by Manufacturer: 04/22/2020
• Supplement Date Received by Manufacturer: 05/20/2020; 06/01/2020
• Initial Report FDA Received Date: 05/05/2020
• Supplement Report FDA Received Date: 05/22/2020; 06/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 130 DEG AIMING ARM; COMPLETE RADIOLUCENT INSERTION HANDLE; PEDICLE ACCESS CANNULA SHAFT; UNK - NAILS: TFNA; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING