MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DRIVING CAP WITH HANDLE ADAPTER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	03.010.047
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Occupation: reporter is a synthes employee.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 or Problem Description
It was reported that on an unknown date the set was brought up by central sterile without both parts of the driving cap.The central sterile staff was unable to locate them and presumed that they were lost.There was no patient involvement.This report is for one (1) driving cap with handle adapter.This is report 1 of 1 for (b)(4).
Additional 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, h6: a product investigation was conducted.Visual inspection: the driving cap with handle adapter (p/n: 03.010.047, lot #: unk) was returned and received at us cq.Upon visual inspection, it was observed that the device was missing a driving cap body.There were scratches on the handle adapter but have no impact on the device functionality.No other issues were observed with the returned device.Dimensional inspection: there was conclusive evidence that the returned device was missing components, so the dimensional inspection was not performed.Document/specification review: since the exact manufactured date of the device was not identified, the current revision of drawings were reviewed.Dhr was not performed due to unknown lot number.Yes, the device received was missing a component.Hence confirming the allegation.Investigation conclusion: the complaint condition was confirmed for the driving cap with handle adapter (p/n: 03.010.047, 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.The components screw together, and it's likely they were disassembled and misplaced during handling.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: DRIVING CAP WITH HANDLE ADAPTER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11337480
• Report Number: 2939274-2021-00898
• Device Sequence Number: 19053507
• Product Code: LXH
• UDI-Device Identifier: 10886982067197
• UDI-Public: 10886982067197
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2021

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
• Operator of Device: Health Professional
• Device Model Number: 03.010.047
• Device Catalogue Number: 03.010.047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2021
• Initial Date Received by Manufacturer: 01/27/2021
• Supplement Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 02/17/2021
• Supplement Report FDA Received Date: 03/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1