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

Model Number	698339374
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the receiving inspection (ri) for retractor clamp assembly was conducted identifying that lot number gm56688mt was released in a single batch july 21, 2020 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.A product investigation was completed: upon visual inspection, it is observed that the device looks good without any visual damages.Functional test was performed.The retractor clamp threaded rod was observed to be stuck on the clamp body and unable to function as intended.Damaged internal threads might have contributed to the stuck condition of the device.Dimensional inspection of the threaded rod was performed.The diameter of the threaded part near stuck location was measured and was within specification.The relevant drawings were reviewed during the investigation; no design issues or discrepancies were noted during the investigation.The complaint condition was confirmed.A definitive root cause could not be determined for the reported problem.There were no issues during the manufacture of this product that would contribute to this complaint condition.During the investigation, no product design issues, or discrepancies were observed that may have contributed to the complaint condition.Based upon these results, 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.Therefore, it has been determined that no corrective and/or preventive action is proposed.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) 2020, when setting up rigid arm for case it was noticed that the part would no longer tighten, and it became cross threaded.A back up set was pulled; there was no disruption to the case.There were no patient consequences.Procedure outcome is unknown.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
• MDR Report Key: 11089408
• Report Number: 1526439-2020-02494
• Device Sequence Number: 11436649
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/06/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 698339374
• Device Catalogue Number: 698339374
• Device Lot Number: GM56688MT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/17/2020
• Initial Report FDA Received Date: 12/29/2020
• Patient Sequence Number: 1