MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SCREWDRIVER STARDRIVE T15/ SELF-RETAINING/272MM; GAUGE,DEPTH

Model Number 03.113.021

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Synthes rep.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.A review of the device history record has been requested.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) 2019, one (1) insertion handle for low bend medial tibial plate right was missing the connecting screw or the aiming arm.It was also mentioned that the rad tech trying to remove the connecting screw from one (1) insertion handle for low bend medial tibial plate which was the left one trying to put it in the right one and upon the connecting screw was cross-threaded with the insertion handle.Lastly, one (1) star drive screwdriver was damaged while trying to remove the connecting screw.There was no patient involvement.This complaint involves two (2) devices.This report is 1 of 2 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.H10: additional narrative: b5/d11: concomitant device.H3, h4, h6: part: 03.113.021, lot: 3707221: manufacturing site: haegendorf.Release to warehouse date: february 17, 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: the screwdriver was received.Visual inspection was performed.The distal tip of the screwdriver is worn and deformed.It shows wear to the point that the most distal tips are no longer present.There are light scratches on the shaft by the distal tip of the device.No other issues were noted.The received condition is consistent with the complaint condition thus confirming the complaint.Dimensional inspection shows the relevant dimensions are conforming.The relevant drawings were reviewed.The complaint was confirmed as it was damaged to the point that the distal tip was stripped/worn.The most distal tip of threads of the tip are no longer present which would make this device inoperable.While no definitive root cause could be determined, the device could have experienced unintended forces during its life cycle.The distal tips could have worn through 8 years of cyclical use and sterilization.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 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

Concomitant device: connecting screw (part unknown, lot unknown, quantity 1).

• Brand Name: SCREWDRIVER STARDRIVE T15/ SELF-RETAINING/272MM
• Type of Device: GAUGE,DEPTH
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8843679
• MDR Text Key: 152913372
• Report Number: 2939274-2019-59457
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982072870
• UDI-Public: (01)10886982072870
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.113.021
• Device Catalogue Number: 03.113.021
• Device Lot Number: 3707221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2019
• Date Manufacturer Received: 08/13/2019
• Patient Sequence Number: 1
• Treatment: UNK - CONNECTING/COUPLING SCREW