MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HANDLE FOR PROTECTION SLEEVES FOR SUPRAPATELLAR; NAIL,FIXATION,BONE

Model Number 03.010.430

Device Problems Use of Device Problem (1670); Device-Device Incompatibility (2919)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A review of the device history record has been requested.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 that during a routine inspection before a case on (b)(6) 2019, the black part of the handle for protection sleeves for suprapatellar that holds the trocars was bent and will not hold them in.There was no patient involvement.Concomitant medical products: unknown trocar (part# unknown, lot# unknown, quantity# unknown).This complaint involves one (1) device.This report is 1 of 1 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d8.H3, h6: a product investigation was conducted.The instrument was inspected at cq, it is observed that the knob portion is no longer sitting flush with the rest of the device; indicating the dowel pin may have become bent and may hinder the functionality of the device.The rest of the device shows normal wear which would not contribute to the complaint condition.Thus, the reported complaint is being confirmed.No new issues were identified.A device failure was identified.Dimensional inspection: dimensional inspection of the received device was not performed due to post manufacturing damage and the complaint feature could not be assessed without damaging the instrument.Documentation/ specification review: the relevant documents were reviewed as part of this investigation: based on the review of the drawings, no design issues contributing to relevant complaint condition were identified.Investigation conclusion: while a definitive root cause could not be determined, it is possible that the device might have encountered unintended forces.No product design or manufacturing issues were identified, and no new malfunctions were identified either.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.H3, h4, h6: a device history record (dhr) review was conducted: part number: 03.010.430; lot number: t957942; manufacturing site: tuttlingen; release to warehouse date: 13-apr-2011.A review of the device history records was performed for the finished device lot number and a nc was started because the surface was dull after electropolishing.The necessary actions to ensure the final product quality have been taken and documented in the appropriate quality system.The nc have no impact to the complaint condition.The final quality release criteria were met before this batch was released for distribution.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: HANDLE FOR PROTECTION SLEEVES FOR SUPRAPATELLAR
• Type of Device: NAIL,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9555410
• MDR Text Key: 182943467
• Report Number: 2939274-2020-00058
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 10886982068712
• UDI-Public: (01)10886982068712
• Combination Product (y/n): N
• PMA/PMN Number: K111667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/10/2019

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
• Device Operator: Health Professional
• Device Model Number: 03.010.430
• Device Catalogue Number: 03.010.430
• Device Lot Number: T957942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2020
• Initial Date Manufacturer Received: 12/10/2019
• Initial Date FDA Received: 01/06/2020
• Supplement Dates Manufacturer Received: 01/16/2020
• Supplement Dates FDA Received: 01/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN TROCAR.