MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SCREWDRIVER HANDLE WITH HEX COUPLING-MEDIUM; SCREWDRIVERS

Model Number 311.006

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Type  malfunction  

Manufacturer Narrative

Without a lot number, the device history records review could not be completed as no product was received.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 on (b)(6) 2020, the sterile processing department (spd) staff informed that the screwdriver handle with hex coupling-medium was broken and can no longer be sterilized or utilized in surgery.There was no patient involvement.This complaint involves one (1) device.This report is for (1) screwdriver handle with hex coupling-medium.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.H10 additional narrative: investigation summary.Visual inspection: the screwdriver handle with hex coupling-medium (p/n: 311.006, lot #: unk) was returned and received at us cq.Upon visual inspection the handle component was observed to be missing.There were scratches on the device but have no impact on the device functionality.Document/specification review since the exact manufactured date of the device was not identified, the current revision of drawings were reviewed driver assembly.Complaint confirmed? yes, the device received was missing handle.Hence confirming the allegation.Investigation conclusion the complaint condition is confirmed for the screwdriver handle with hex coupling-medium (p/n: 311.006, lot #: unk).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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 history lot: lot number unknown.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: SCREWDRIVER HANDLE WITH HEX COUPLING-MEDIUM
• Type of Device: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11089792
• MDR Text Key: 224600611
• Report Number: 2939274-2020-05756
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 10887587035598
• UDI-Public: (01)10887587035598
• 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,health
• Type of Report: Initial,Followup
• Report Date: 12/02/2020

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: 311.006
• Device Catalogue Number: 311.006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2020
• Initial Date Manufacturer Received: 12/02/2020
• Initial Date FDA Received: 12/29/2020
• Supplement Dates Manufacturer Received: 01/13/2020
• Supplement Dates FDA Received: 01/22/2021
• Patient Sequence Number: 1