MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC OPAL IMPLANT HOLDER PISTOL GRIP; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	03.803.002
Medical Device Problem Codes	Compatibility Problem (2960); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j 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 or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that during an unknown surgery on an unknown date is 2020, the knob that attaches to the back of the inserter handle is cross threaded and will not release.No further information provided.This report is for one (1) opal implant holder pistol grip.This is report 1 of 1 for (b)(4).

• Brand Name: OPAL IMPLANT HOLDER PISTOL GRIP
• 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: 11132009
• Report Number: 2939274-2021-00065
• Device Sequence Number: 10931831
• Product Code: LXH
• UDI-Device Identifier: 10705034722450
• UDI-Public: (01)10705034722450
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/08/2020

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
• Operator of Device: Health Professional
• Device Model Number: 03.803.002
• Device Catalogue Number: 03.803.002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2020
• Initial Report FDA Received Date: 01/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1