MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SHAFT FOR 90° SCREWDRIVER; DRILL, BONE, POWERED

Model Number 03.505.004

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Additional product code: dzj, hxx.Occupation: synthes employee.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed; 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 on an unknown date, two (2) matrix rib 90 degree screwdriver shafts and 2 screwdriver handles did not fully tighten screws to a plate.Another 90-degree screw driver set was opened, and it functioned as intended.It is unknown if there was surgical delay.Procedure was successfully completed.Patient outcome was unknown.Concomitant devices reported: unknown screws (part number: unknown, lot number: unknown, quantity: unknown), unknown plate (part number: unknown, lot number: unknown, quantity: 1).This is report 3 of 4 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: 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.

• Brand Name: SHAFT FOR 90° SCREWDRIVER
• Type of Device: DRILL, BONE, POWERED
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9473535
• MDR Text Key: 196424494
• Report Number: 2939274-2019-62672
• Device Sequence Number: 1
• Product Code: DZI
• UDI-Device Identifier: 10887587013305
• UDI-Public: (01)10887587013305
• Combination Product (y/n): N
• PMA/PMN Number: K082649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.505.004
• Device Catalogue Number: 03.505.003
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HANDLE FOR 90° SCREWDRIVER; SHAFT FOR 90° SCREWDRIVER