MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFCSTEINMN PIN/DRIL PAK STERIL; FIXATION PINS

Catalog Number	864192
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/25/2025
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that before opening the pin pack, the nurse observed plastic seal was compromised and questioned sterility.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.According to the information received, ¿it was reported that before opening pin pack nurse observed plastic seal was compromised and questioned sterility.¿ product description:- pfcsteinmn pin/dril pak steril product code:- 864192, lot no:- m7669d, quantity of manufactured:- (b)(4), date of manufacturing:- 28-oct-2024, expiry date:- 30-sept-2034.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.If additional information is made available, the investigation will be updated as applicable.Device history lot : product description:- pfcsteinmn pin/dril pak steril product code:- 864192, lot no:- m7669d, quantity of manufactured:- (b)(4), date of manufacturing:- 28-oct-2024, expiry date:- 30-sept-2034.Device history review : a manufacturing record evaluation was performed for the finished device, and no non-conformances / manufacturing irregularities were identified.
Additional 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.H11 additional narrative: added: d9.If information that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: it was reported that before opening pin pack nurse observed plastic seal was compromised and questioned sterility.The product was returned to j&j medtech orthopaedics for evaluation.The complaint unit was forwarded to the manufacturing site j&j medtech orthopaedics raynham.Visual analysis of the returned device revealed that the inner retaining tray was deformed.No other damage was identified.The observed condition of the device has been addressed through the j&j medtech orthopaedics quality management system.Based on the manufacturing investigation, the complaint was isolated to the retaining tray and no sterile barrier was compromised.The packaging and seal were intact and sterility was maintained therefore, the defect poses no patient harm or impact.During the packaging process, the warped retaining tray was not identified as nonconforming and all procedures were followed as intended.Therefore, no assignable cause for the defect resulting in the complaint could be identified.A manufacturing record evaluation was performed for the finished device product code 864192 lot number m7669d, and no non-conformances / manufacturing irregularities were identified during manufacturing.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was not confirmed as the observed condition of the pfcsteinmn pin/dril pak steril would not have contributed to the complained 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 j&j medtech orthopaedics 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: a manufacturing record evaluation was performed for the finished device product code 864192 lot number m7669d, and no non-conformances / manufacturing irregularities were identified during manufacturing.H11 additional narrative: corrected: h3.

• Brand Name: PFCSTEINMN PIN/DRIL PAK STERIL
• Common Device Name: FIXATION PINS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 21686199
• Report Number: 1818910-2025-04471
• Device Sequence Number: 9282375
• Product Code: HTW
• UDI-Device Identifier: 10603295216476
• UDI-Public: (01)10603295216476(17)340930(10)M7669D
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup

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
• Operator of Device: Health Professional
• Device Catalogue Number: 864192
• Device Lot Number: M7669D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/26/2025
• Supplement Date Received by Manufacturer: 04/08/2025; 06/24/2025; 10/24/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 04/09/2025; 06/26/2025; 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male