MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 HUMERAL STEM PIN PUNCH; SHOULDER INSTRUMENT - PIN PUNCH

Model Number 6201-01-121

Device Problem Break (1069)

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

Event Date 05/18/2022

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 pegs fell out of alignment guide.

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).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 confirmed that the pin punch used with the blazer.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary: the device associated with this report was returned.After physical review, it was identified, that the 2 humeral punch pins broken off from the rest of the device.Therefore, the allegation can be confirmed.No other issues were observed.Depuy synthes considers, the investigation closed at this time.Should additional information be received, the information will be reviewed.And the investigation may be re-opened as necessary.Device history lot: a manufacturing record evaluation was performed, for the finished device (p/n: 620101121, lot#: 173559).And no previous non-conformances or manufacturing irregularities were identified in the depuy synthes quality system.

• Brand Name: HUMERAL STEM PIN PUNCH
• Type of Device: SHOULDER INSTRUMENT - PIN PUNCH
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14597661
• MDR Text Key: 293336582
• Report Number: 1818910-2022-10107
• Device Sequence Number: 1
• Product Code: MBF
• UDI-Device Identifier: 10603295539315
• UDI-Public: 10603295539315
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202716
• 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: 06/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6201-01-121
• Device Catalogue Number: 620101121
• Device Lot Number: 173559
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2021
• 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