MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC AIMING ARM FOR 4.5MM VA-LCP CURVED CONDYLAR PLATE/RIGHT; SCREW, FIXATION, BONE

Model Number	03.231.004
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional product codes: jdp, hrs.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 aiming arm.This is report 1 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.H10 additional narrative: h3, h4, h6: a device history record (dhr) review was conducted: part: 03.231.004.Lot: 7554389.Manufacturing site: haegendorf.Release to warehouse date: 02.Sep.2011.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.H3, h6: a product investigation was conducted.Visual inspection: visual inspection of the returned right aiming arm assembly for va-lcp curved condylar plate / right revealed that the internal threads of the aiming arm are stripped off.So, the screws were not able to couple with the aiming arm.Thus, confirming the complaint condition.Additionally, a minimal wear of the surface of the aiming arm was noticed which would not contribute to 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: dimensional inspection of the mounting sleeve¿s hole measured and is within specification per relevant drawing.Document/specification review: the relevant drawings were reviewed during investigation: no design issues were noted during investigation.Investigation conclusion: the complaint was confirmed during investigation.Due to the stripped internal threads of the aiming arm, 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.
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.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.

• Brand Name: AIMING ARM FOR 4.5MM VA-LCP CURVED CONDYLAR PLATE/RIGHT
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8399193
• Report Number: 2939274-2019-56855
• Device Sequence Number: 2029659
• Product Code: HWC
• UDI-Device Identifier: 10886982077318
• UDI-Public: (01)10886982077318
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K110354
• 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: 03.231.004
• Device Catalogue Number: 03.231.004
• Device Lot Number: 7554389
• 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; 04/22/2019
• 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