MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC COUPLING BOLT FOR LCP PERIARTICULAR AIMING ARMS; MISC ORTHO SURGICAL INSTR

Model Number	03.120.030
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Patient Involvement (2645)
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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 on (b)(6) 2019, upon inspection in the sterile processing department (spd), two (2) coupling bolts appeared to have damage to the starting threads, and the devices could not be screwed into the aiming arm.It was noted that the threads on the aiming arm were also damaged.There was no patient involvement.This report is for a coupling bolt.This is report 2 of 3 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.E1: initial reporter contact information.H3, h6: the device was received, and the product evaluation is in progress.No conclusion can be drawn.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.A device history record (dhr) review was conducted: part# 03.120.030.Note (agile/sap internal item # is 60040729).Lot#7563733.Manufacturing location: hagendorf.Released to warehouse date: 14sept2011.No non-conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.A product investigation was conducted.Visual inspection: coupling bolt for lcp periarticular aiming arms was received at cq.Upon visual inspection at cq, it was noticed that the threads of the bolt were stripped off.So, the screws were not able to couple with the aiming arm.Thus, confirming the complaint condition.Functional testing: functional testing could not be performed as the insertion handle was not returned and screws were not able to couple with the aiming arm.The received condition agrees with the complaint description.The complaint could not be replicated during investigation.Dimensional inspection: the diameter of the threaded portion of the coupling bolt for lcp periarticular aiming arms was measured and is within specification.Document/specification review: the relevant drawing was reviewed during investigation: no design issues were noted during investigation.Investigation conclusion: the complaint was confirmed during investigation.Due to the stripped threads of the coupling bolt, the screws were not able to couple with the aiming arm.No manufacturing issues were identified during investigation.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.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: COUPLING BOLT FOR LCP PERIARTICULAR AIMING ARMS
• 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: 8399240
• Report Number: 2939274-2019-56856
• Device Sequence Number: 2054044
• Product Code: LXH
• UDI-Device Identifier: 10886982074270
• UDI-Public: (01)10886982074270
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/04/2019

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 Model Number: 03.120.030
• Device Catalogue Number: 03.120.030
• Device Lot Number: 7563733
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2019
• Initial Date Received by Manufacturer: 03/04/2019
• Supplement Date Received by Manufacturer: 03/28/2019; 04/17/2019
• Initial Report FDA Received Date: 03/07/2019
• Supplement Report FDA Received Date: 04/03/2019; 04/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1