MAUDE Adverse Event Report: DEPUY SPINE INC ROD APPROX W/DOVETAIL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 279712525

Device Problem Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/24/2022

Event Type  malfunction  

Event Description

Device report from depuy reports an event in singapore as follows: it was reported that rod approximator from expedium set was jammed on the screwhead and could not be removed.Surgeon had to break it in order to release it.There was surgical delay of 120 minutes due to the reported event.The surgery was successfully completed.This report is for one (1) rod approx w/dovetail.This is report 1 of 1 for complaint (b)(4).

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.Complainant part is not expected to be returned for manufacturer review/investigation.Photo investigation: the photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device photos.Visual analysis of the photo revealed that the rod approx.W/dovetail, p/n: 279712425, was covered in bodily fluids.No significant product problems were identified.The allegation of jammed/seized can not be confirmed.Functionality issues can not be assessed through a photo investigation.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed for rod approx.W/dovetail, p/n: 279712425.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.Device history record (dhr) review: part # 279712525.Lot # 0310mi.Supplier: (b)(4).Batch1: lot qty of (b)(4) units were released on 25 mar 2010 with no discrepancies.No 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.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 APPROX W/DOVETAIL
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 16600917
• MDR Text Key: 312226153
• Report Number: 1526439-2023-00579
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10705034198972
• UDI-Public: (01)10705034198972
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 279712525
• Device Catalogue Number: 279712525
• Device Lot Number: 0310MI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1