MAUDE Adverse Event Report: DEPUY SPINE INC RETRACTOR CLAMP ASSEMBLY; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	698339374
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2022
Type of Reportable Event	Malfunction
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.Additional narrative: reporter is a synthes employee.Part: 698339374.Lot: gm55202mt.Supplier: seabrook ¿ batch1: released on (b)(6) 2019 with no discrepancies.No nonconformance reports (ncrs) were generated during production.The ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the retractor clamp assembly showed signs of corrosion at the threads.In addition, the threads were worn.The clamp threaded rod was broken at the bottom.The broken fragments were not returned.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional test was performed by hand and the clamp was noted jammed.A review of the receiving inspection (ri) was performed for the finished device [gm55202mt] number, and no issues were identified.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the retractor clamp assembly would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.Drawing/specifications reviewed: current and manufactured revisions were reviewed.No design issues or discrepancies were identified.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 during a procedure on (b)(6) 2022, the retractor clamp assembly was cross threaded.Procedure was completed with no delay.There was no patient consequence.Upon manufacturer investigation, it was determined that the clamp was jammed.This report is for a retractor clamp assembly.This is report 1 of 1 for (b)(4).

• Brand Name: RETRACTOR CLAMP ASSEMBLY
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 14842233
• Report Number: 1526439-2022-00955
• Device Sequence Number: 16739339
• Product Code: LXH
• UDI-Device Identifier: 10705034457123
• UDI-Public: (01)10705034457123
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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

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: 698339374
• Device Catalogue Number: 698339374
• Device Lot Number: GM55202MT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/28/2022
• Initial Report FDA Received Date: 06/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2019
• 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
• Patient Sex: Unknown