MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC GEAR COVER FOR SCREWDRIVER 90; DRIVER, WIRE, AND BONE DRILL, MANUAL

Model Number 03.505.007

Device Problem Break (1069)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Additional device product codes: dzi.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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 an unknown date the patient underwent a re-open surgery for the removal of remained foreign object.Initially on (b)(6) 2021, the patient underwent a rib plating and open reduction internal fixation (orif) procedure to treat ulnar fracture from a motor vehicle accident.During the procedure the device used to secure screws came apart vs failed at the end of the procedure.X-ray taken after closure of procedure showed a significant foreign object in subcutaneous tissue.Patient was not removed from the operating room and was not extubated from the initial procedure.This report captures the re-opening of the patient for the removal of the foreign body object post-operatively, while related complaint (b)(4) (mw5100352) captures the intra-op event where the device used to secure screws came apart vs failed at the end of the rib plating procedure.This report is for one (1) gear cover for screwdriver 90.This is report 2 of 2 for complaint (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, h4, h6- the device was not returned.A photo-investigation was performed on the images located in pc attachment ¿(b)(4) additional information with device photo received from healthcare professional 11jun2021".The attachment has images of the gear cover for screwdriver 90 (image circled in red and referred as "retained item").The device was not assembled with mating part as it appears unattached; thus the complaint is confirmed.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.Conclusion: the complaint condition was confirmed during photo investigation.However the device did not appear broken (separated in 2 or more pieces).No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventive 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: the device lot number is unknown, therefore a mre review could not be performed.If more information become available, the record will be re-assessed.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: GEAR COVER FOR SCREWDRIVER 90
• Type of Device: DRIVER, WIRE, AND BONE DRILL, MANUAL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11923990
• MDR Text Key: 253971291
• Report Number: 2939274-2021-02737
• Device Sequence Number: 1
• Product Code: DZJ
• UDI-Device Identifier: 10887587013336
• UDI-Public: (01)10887587013336
• 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: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.505.007
• Device Catalogue Number: 03.505.007
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention