MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.5/2.0 CRUC SCRWDRVR SFT, SLF-RETAINING; SCREWDRIVERS

Model Number	313.993
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant device is not expected to be returned for manufacturer review/investigation.Initial reporter is j&j company representative.Without a lot number the device history records review could not be completed.The investigation could not be completed.No conclusion could be drawn, as no product was received.The investigation could not be completed.No conclusion could be drawn, as no product was received.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 (b)(6) 2021 some instruments that were broken during a case.It is unknown if there were fragments generated or if they were retrieved.It is unknown if there is surgical delay reported and if the procedure was successfully completed.This complaint involves five (5) devices.This report is for one (1) 1.5/2.0 cruc scrwdrvr sft, slf-retaining.This report is 5 of 5 for complaint (b)(4).

• Brand Name: 1.5/2.0 CRUC SCRWDRVR SFT, SLF-RETAINING
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11755644
• Report Number: 2939274-2021-02168
• Device Sequence Number: 3192341
• Product Code: HXX
• UDI-Device Identifier: 10886982188359
• UDI-Public: (01)10886982188359
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Type of Report: Initial
• Report Date (Section B): 04/07/2021

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: 313.993
• Device Catalogue Number: 313.993
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 04/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1