MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HEX ADAPTOR-QC HIGH-STRENGTH; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	03.617.941
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If the information is unknown, not available or does not apply, the section/field of the form is left blank.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 (b)(6) 2021, during an anterior cervical discectomy and fusion, the angled driver was broken while inserting the 2nd screw.The adapter was cleanly broken where it connects to the handle and part of the adapter remained in the handle.No fragments were generated.The surgeon used a straight screw driver to finish the procedure.There was no surgical delay.The procedure was successfully completed.There was no patient consequence.This report is for one (1) hex adaptor-qc high-strength.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h4, h6: part: 03.617.941.Lot: 82p3040.Manufacturing site: haegendorf.Release to warehouse date: january 12, 2021.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the hex adaptor-qc high-strength was received at us customer quality (cq).Visual inspection of the device showed that the shaft is broken.The broken off piece was returned with the device.No other defects were noted with the device.The received photo was also reviewed and no additional information was noted.Dimensional inspection: the relevant dimensions cannot be measured due to post manufacturing damage.Document/specification review: current and manufactured revisions were reviewed.No design or manufacturing discrepancies were noted.Conclusion: the complaint is confirmed for the returned device as it was noted that the shaft of the device was broken.A definitive assignable root cause cannot be determined from the provided information.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: HEX ADAPTOR-QC HIGH-STRENGTH
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12627911
• Report Number: 2939274-2021-06099
• Device Sequence Number: 14520713
• Product Code: HWE
• UDI-Device Identifier: 10705034717272
• UDI-Public: 10705034717272
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2021

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: 03.617.941
• Device Catalogue Number: 03.617.941
• Device Lot Number: 82P3040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/15/2021
• Supplement Date Received by Manufacturer: 10/18/2021
• Initial Report FDA Received Date: 10/13/2021
• Supplement Report FDA Received Date: 11/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CERVIC-SPINE-SCR Ø3.7 SELF-DRILL 16 TAN; CERVIC-SPINE-SCR Ø3.7 SELF-DRILL 16 TAN; RATCHET-SCRDRIVER HANDLE W/HEX-COUPL; RATCHET-SCRDRIVER HANDLE W/HEX-COUPL; SHAFT F/ANGL SCREWDRIV W/QUICK-COUPL; SHAFT F/ANGL SCREWDRIV W/QUICK-COUPL
• Patient Age: 72 YR
• Patient Sex: Male