MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US COR/TRI ANT STEM INSERT SHAFT; HIP INSTRUMENTS : INSERTION DEVICES

Catalog Number 259807440

Device Problems Break (1069); Naturally Worn (2988)

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

Event Date 04/01/2024

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.

Event Description

It was reported that the daa curved insert tip is broken.

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.

Event Description

Additional information received: a.Did it break into two or more pieces? if no, please specify what is the alleged deficiency of the instrument.Is it bent, cracked, stripped, worn, or cross-threaded? no parts or debris.

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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.

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 that 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.Added: b5, d4 (lot), h6 medical device problem code.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Was it worn, broken into two or more pieces, cracked, or stripped? it is worn i have circled the broken instrument.

Manufacturer Narrative

Product complaint (b)(4) investigation summary update may 3, 2024 according to the information received, " daa curved insert tip is broken" the product was not returned to depuy synthes, however photos were provided for review.See attachment ¿image 2 a-11032159 source data.Msg, image 1 a-11032159 source data.Msg¿ the photo investigation revealed that (259807440, cor/tri ant stem insert shaft) had broken curved insert tip.The observed condition of the device was consistent with a component failure that may have been caused by exposure to unintended forces, like [hitting heavy off-axis on the handle anvil, using forceps/pincers/tweezers on the radel handle, hitting from the bottom up].Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the cor/tri ant stem insert shaft would contribute to the complained device issue.Based on the investigation findings, potential cause can be attributed to unintended use error caused or contributed to event and 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 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.

• Brand Name: COR/TRI ANT STEM INSERT SHAFT
• Type of Device: HIP INSTRUMENTS : INSERTION DEVICES
• 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 ; 3035526892
• MDR Report Key: 19093974
• MDR Text Key: 340130298
• Report Number: 1818910-2024-08159
• Device Sequence Number: 1
• Product Code: HWR
• UDI-Device Identifier: 10603295148425
• UDI-Public: 10603295148425
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/11/2024

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 Catalogue Number: 259807440
• Device Lot Number: PG256335
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/09/2024
• Initial Date FDA Received: 04/11/2024
• Supplement Dates Manufacturer Received: 04/11/2024; 04/23/2024; 04/30/2024; 04/29/2024; 05/12/2024
• Supplement Dates FDA Received: 04/15/2024; 04/25/2024; 04/30/2024; 05/02/2024; 05/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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