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

Model Number 03.505.004

Device Problems Material Twisted/Bent (2981); Naturally Worn (2988)

Patient Problem No Patient Involvement (2645)

Event Date 07/23/2019

Event Type  malfunction  

Manufacturer Narrative

Additional pro-codes: dzj, hxx.Complainant part is not expected to be returned for manufacturer review/investigation.Occupation: synthes rep.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.Investigation summary product was not returned.Based on the information available, it has been determined that no corrective and 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 Description

It was reported that on (b)(6) 2019, during unknown intra-operation surgery, the shaft for 90 degree screwdriver would not put in screw into the patient and it kept stripping out.The procedure was successfully completed with a delay of 5 minutes using a new set of different screwdrivers.Patient status was unknown.This complaint involves ten (10) devices.This report is for one (1) handle for 90° screwdriver.This report is 2 of 10 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.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 further reported that no screws were stripped, the screwdriver was not seating the screws into the plate.

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.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.B5: subsequent follow-up with the reporter, additional information was received.Updated event description: it was reported that on (b)(6) 2019, during unknown intra-operation surgery, the shaft for 90 degree screwdriver would not put in screw into the patient and it kept stripping out.The procedure was successfully completed with a delay of 5 minutes using a new set of different screwdrivers.Patient status was unknown.It was reported that there was an allegation on the handle for 90° screwdriver as this was part of the entire device.It was reported that there was an allegation on the matrixrib screwdriver blade self-retaining f/90° scrwdrvr as this was part of the entire device.It was reported that there was an allegation on the 90 degree screwdriver t-handle as this was part of the entire device.It was reported that there was no allegation on the screw.It was reported that the screw would not turn due to the device of the 90 degree screwdriver.It was reported that no screws were stripped.It was reported that the screwdriver was not seating the screws into the plate.Concomitant device reported: unk - plates: trauma (part # unknown, lot # unknown, quantity # unknown).This complaint involves thirteen (13) devices.

• Brand Name: HANDLE 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: 8908386
• MDR Text Key: 155034623
• Report Number: 2939274-2019-59925
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2019
• 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: 03.505.004
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1