MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ROD ROTATION WRENCH FOR 5.5MM/6.0MM HEX-END RODS

Model Number	03.632.020
Medical Device Problem Code	Compatibility Problem (2960)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2021
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.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 on (b)(6) 2021 during a scoliosis procedure, the rod rotation wrench was not able to properly hold the rod.There was no surgical delay.There was no patient consequence.The procedure was successfully completed using another wrench.This report is for one (1) rod rotation wrench for 5.5mm/6.0mm hex-end rods.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, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.
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, h4, h6: part number: 03.632.020.Lot number: t945058.Manufacturing site: tuttlingen.Release to warehouse date: april 27, 2010.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the wrench-hex f/r ø5.5/6 f/matrix (part #: 03.632.020, lot #: t945058) was received at us customer quality (cq).Visual inspection of the complaint device showed that both hex-end's edges were worn and rounded; hence deformed.No other defect was observed.Functional test: a functional assessment was not performed with the complaint device since the rod was not returned.Can the complaint be replicated with the returned device? no the complaint could not be replicated.Dimensional inspection: no dimensional inspection was performed due to the post-manufacturing damage.Document/specification review: current and manufactured revisions were reviewed.No design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as both hex-ends were worn and rounded at the edges.As the rod was not returned, the functional assessment could not be performed and the reported condition could not be confirmed.However, the defect observed on the hex-ends could definitely cause the wrench to strip while attempting to rotate the rod; hence the complaint is confirmed.No root cause could definitively be determined base on the information provided but it is likely the deformation of the sharp edges could be due to multiple usage of the device contributing to its wear.This failure mode is an indication of end of life.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.No design issues were observed during the document/specification review.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 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: ROD ROTATION WRENCH FOR 5.5MM/6.0MM HEX-END RODS
• Common Device Name: WRENCH
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11845855
• Report Number: 2939274-2021-02424
• Device Sequence Number: 11766596
• Product Code: HXC
• UDI-Device Identifier: 10705034718811
• UDI-Public: 10705034718811
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup,Followup
• Report Date (Section B): 04/21/2021

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: 03.632.020
• Device Catalogue Number: 03.632.020
• Device Lot Number: T945058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 06/15/2021; 06/18/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 06/15/2021; 07/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1