MAUDE Adverse Event Report: DEPUY SPINE INC. REDUCTION THREADED POST; ORTHOPAEDIC IMPLANT INSERTER/EXTRACTOR, REUSABLE

Model Number	286735730
Medical Device Problem Codes	Device Slipped (1584); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from depuy synthes reports an event in germany as follows: this is report 5 of 5 for (b)(4).It was reported by the sales rep in (b)(6) that during an inspection, it was observed that the small inner springs on the implant inserter/extractor device were loose; and that the pen did not hold on the shaft any longer.There was no procedure nor patient involvement reported.No additional information was provided.This report is for one (1) reduction threaded post device.This complaint involves 5 devices.
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.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a j&j sales representative.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.
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.H4: device history: part #: 286735730, lot #: mi63505, supplier: (b)(4).Batch 1: lot qty of (b)(4) units were released on 20 jun 2018 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.
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: d4, h4: the expiration date was reported as unknown on the initial report; and has been updated accordingly.Investigation summary: 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 spring inside reduction threaded post, p/n: 286735730, was missing.No other problem identified.A dimensional inspection was unable to be performed due to device design.A functional test was not conducted since the mating device was not returned.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 reduction threaded post, p/n: 286735730 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.Device history review: a review of the receiving inspection (ri) for reduction threaded post was conducted on lot number mi63506; and identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.H10: correction narrative: d4, h4: the lot number has been updated to reflect the correct information.Therefore, the device manufacture date was updated accordingly.

• Brand Name: REDUCTION THREADED POST
• Common Device Name: ORTHOPAEDIC IMPLANT INSERTER/EXTRACTOR, REUSABLE
• 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: 14193090
• Report Number: 1526439-2022-00605
• Device Sequence Number: 4677050
• Product Code: LXH
• UDI-Device Identifier: 10705034214665
• UDI-Public: 10705034214665
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

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: 286735730
• Device Catalogue Number: 286735730
• Device Lot Number: MI63506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2022
• Supplement Date Received by Manufacturer: 08/09/2022; 08/09/2022
• Initial Report FDA Received Date: 04/25/2022
• Supplement Report FDA Received Date: 06/22/2022; 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2018
• 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