MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CANNULATED 4.0MM HEXAGONAL SCREWDRIVER

Model Number 314.05

Device Problem Break (1069)

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

Event Date 10/03/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter is synthes sales representative.Without a lot number the device history records review could not be completed.Product was not returned.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.

Event Description

It was reported that on (b)(6) 2020, the patient underwent an unknown procedure.While the surgeon was inserting the screw, the screw driver broke off.There were no fragments generated from the broken device.The surgeon grabbed another screw driver to complete the procedure.There was no surgical delay reported.The procedure was completed successfully.There was no patient consequence reported.Concomitant device reported: unknown screw (part# unknown, lot# unknown, quantity 1).This report is for one (1) cannulated 4.0mm hexagonal screwdriver.This is report 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: h3, h6: due to the age of more than 15 years of the complained device a wear or use related root cause is the most likely reason of the complained malfunction.Per procedure for complaints for which a non-manufacturing related probable cause has been identified, no manufacturing record evaluation is required.Visual inspection: the cannulated 4.0mm hexagonal screwdriver was received at us customer quality (cq).The visual inspection of the received device indicated that the distal hex tip was broken.The received image was reviewed and contributed no additional information.No other issues were identified with the returned device.Dimensional inspection: the dimensional inspection cannot be performed due to post-manufacturing damage.Document/specification review: the drawings reflecting current and manufactured revisions were reviewed.Investigation conclusion: the complaint was confirmed for the received device as the distal hex tip was broken.While no definitive root cause could be determined based on the provided information, it is possible that the device was encountered unintended forces.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.

• Brand Name: CANNULATED 4.0MM HEXAGONAL SCREWDRIVER
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11096146
• MDR Text Key: 224414743
• Report Number: 2939274-2020-05769
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 10886982188410
• UDI-Public: (01)10886982188410
• 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: 12/03/2020

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: 314.05
• Device Catalogue Number: 314.05
• Device Lot Number: A4DD007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2020
• Initial Date Manufacturer Received: 12/03/2020
• Initial Date FDA Received: 12/30/2020
• Supplement Dates Manufacturer Received: 12/29/2020
• Supplement Dates FDA Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA