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

Model Number 03.231.003

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The device was received, the investigation is in progress, 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 Description

It was reported on (b)(6) 2020, an aiming arm left not lining up with plate holes when they have a plate attached to the insertion handle, aiming arm right not lining up with plate holes when they have a plate attached to the insertion handle, and insertion handle seems to be out of sink with both aiming arms.It is was discovered during an inspection.There was no patient involvement this complaint involves 3 devices.This is report 2 of 3 for (b)(4).

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, h4, h6: part 03.231.003, lot 3798936: manufacturing site: hägendorf.Release to warehouse date: july 21, 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 completed: upon visual inspection, it is observed that the device shows normal wear consistent with the device use which would not contribute to the complaint condition.The left aiming arm was assembled and disassembled with insertion handles without any issues.But complete functional testing of the received device was not performed as the mating plates were not returned.Dimensional inspection of the received device was not performed as no physical damage was evident that could contribute to the complaint condition.The relevant drawings were reviewed during the investigation; no design issues or discrepancies were noted during the investigation.The complaint condition cannot be confirmed.A definitive root cause could not be determined for the reported problem.There were no issues during the manufacture of this product that would contribute to this complaint condition.During the investigation, no product design issues, or discrepancies were observed that may have contributed to the complaint condition.Based upon these results, 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.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: AIMING ARM FOR 4.5MM VA-LCP CURVED CONDYLAR PLATE/LEFT
• Type of Device: CONDYLAR PLATE FIXATION IMPLANT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10943270
• MDR Text Key: 219507278
• Report Number: 2939274-2020-05412
• Device Sequence Number: 1
• Product Code: JDP
• UDI-Device Identifier: 10886982077301
• UDI-Public: (01)10886982077301
• Combination Product (y/n): N
• PMA/PMN Number: K110354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.231.003
• Device Catalogue Number: 03.231.003
• Device Lot Number: 3798936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2020
• Date Manufacturer Received: 12/17/2020
• Patient Sequence Number: 1
• Treatment: INSERTION HANDLE FOR 4.5MM VA-LCP CONDYLAR PLATE; INSERTION HANDLE FOR 4.5MM VA-LCP CONDYLAR PLATE