MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 RECLAIM PROX NECK TRL 40MM; RECLAIM INSTRUMENTS : FEMORAL TRIALS

Model Number 2975-31-040

Device Problems Loose or Intermittent Connection (1371); Device-Device Incompatibility (2919); Mechanical Jam (2983)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/23/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).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 reclaim trial neck and body are not functioning properly.The neck will spin on the body due to the body being worn.Also, the neck tend to get stuck in the locked position.These are the original trial necks that have since been redesigned.No surgical delay.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : the instrument associated with this report was not returned.Depuy-synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.

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.Corrected: h6 (device) from device-device incompatibility to mechanical jam.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).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 states that the instrument did not break into two pieces.The grooves on the proximal body was the feature that was worn and not making it function.

Manufacturer Narrative

Product complaint # (b)(4).All medical device reports associated with the same/similar device(s) and functional : loose were reviewed.It was determined functional : loose has not caused or contributed to any deaths or serious injuries within the time period of jan 1, 2018 ¿ july 12 2022.In total, there have been zero serious injuries and zero deaths reports related to visual : functional : loose in the last 4.5 years.Based on the data, the likelihood of a death or serious injury occurring as a result of the failure is remote; therefore, functional : loose associated with same/similar device(s) of this report will no longer be reported as a medical device report (mdr) unless the event results in a reportable event per 21 cfr 803.50.

• Brand Name: RECLAIM PROX NECK TRL 40MM
• Type of Device: RECLAIM INSTRUMENTS : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 10339765
• MDR Text Key: 200849098
• Report Number: 1818910-2020-17160
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295156369
• UDI-Public: 10603295156369
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2975-31-040
• Device Catalogue Number: 297531040
• Device Lot Number: A0211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2011
• 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: 56 YR
• Patient Sex: Female