MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CONTROL CABLE PASSER HANDLE; HIP INSTRUMENTS : HANDLES

Model Number 2739-10-000

Device Problem Structural Problem (2506)

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

Event Date 08/31/2022

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).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 information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the locking mechanism is defective on this handle and it must be replaced.It is creating a malfunction of the cable passer resulting in complicated use of instrument.There was a surgical delay of two minutes.

Manufacturer Narrative

Product complaint # (b)(4)/ investigation summary no device associated with this report was received for examination.The investigation could not verify or draw any conclusions about the root cause of the reported event without the device to examine.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.H10 additional narrative: added: a1, a2 (age) and a3 corrected: h4.

Manufacturer Narrative

Product complaint (b)(4) investigation summary it was reported that the locking mechanism is defective on this handle and it must be replaced.It is creating a malfunction of the cable passer resulting in complicated use of instrument.There was a surgical delay of two minutes.The device associated with this report was returned to depuy synthes for evaluation.Visual analysis of the returned sample revealed that control cable passer handle was found with no defect.The reported allegation cannot be confirmed.A functional test could not be performed as the mating device was not returned.The overall complaint was unconfirmed as the observed condition of the control cable passer handle would not contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed added: g4 (510k).

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: CONTROL CABLE PASSER HANDLE
• Type of Device: HIP INSTRUMENTS : HANDLES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15428786
• MDR Text Key: 299986260
• Report Number: 1818910-2022-17971
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10603295152033
• UDI-Public: 10603295152033
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K934557
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/15/2022

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
• Device Operator: Health Professional
• Device Model Number: 2739-10-000
• Device Catalogue Number: 273910000
• Device Lot Number: AK0302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/31/2022
• Initial Date FDA Received: 09/15/2022
• Supplement Dates Manufacturer Received: 10/04/2022; 06/15/2023; 09/28/2023
• Supplement Dates FDA Received: 10/04/2022; 06/16/2023; 09/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2002
• 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
• Patient Age: 70 YR
• Patient Sex: Female