MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 UNK FIXATION PIN

Catalog Number UNK FIXATION PIN

Device Problems Break (1069); Device-Device Incompatibility (2919)

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

Event Date 03/22/2024

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.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 surgeon was pinning the distal femoral block and started putting the pin in at an angle.The pin became stuck in the cutting block.Staff opened another cutting block and the rest of the case proceeded as normal.There was no issue to the patient.A total of less than one minute delay was observed.A portion of the pin did break in spd after the case when the staff tried to remove the pin from the block.There were no pieces broken intra op, and therefore no pieces to retrieve from the patient.The block is being returned with the pin cold welded in it.

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.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: it was reported that the surgeon was pinning the distal femoral block and started putting the pin in at an angle.The pin became stuck in the cutting block.Staff opened another cutting block and the rest of the case proceeded as normal.There was no issue to the patient.A total of less than one minute delay was observed.A portion of the pin did break in spd after the case when the staff tried to remove the pin from the block.There were no pieces broken intra op, and therefore no pieces to retrieve from the patient.The block is being returned with the pin cold welded in it.The device associated with this report was returned to depuy synthes for evaluation.Visual analysis of the returned device found that an unk fixation pin was stuck inside at one of the insertion holes of the attune distal fem cut block, also the pin was broken.The broken fragment was not returned for evaluation.The observed condition of the device was consistent with off axis insertion and an exposure to unintended forces, like usage of excessive force in a prying motion.A functional test was performed and was able to replicate the reported condition due to the devices do not disengage as intended.A dimensional inspection was not performed due to post manufacturing damage.The overall complaint was confirmed as the observed condition of the unk fixation pin would have contributed to the complained issue.Based on the investigation findings, the potential cause is traced to unintended use error.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 device lot number is unknown, therefore a device history review could not be performed.If more information become available, the record will be re-assessed.

• Brand Name: UNK FIXATION PIN
• Type of Device: FIXATION PIN
• 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: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19018288
• MDR Text Key: 339089688
• Report Number: 1818910-2024-07178
• Device Sequence Number: 1
• Product Code: LPH
• 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
• Report Date: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK FIXATION PIN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: No
• 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: 73 YR
• Patient Sex: Female
• Patient Weight: 54 KG