MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN CAN BONE SCREW 6.5MMX50MM; BONE SCREWS AND PINS : SCREWS

Catalog Number	121750500
Medical Device Problem Code	Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the sterile package did not open up properly and therefore could not be safely passed off to the surgical field.The implant and its box were kept and will be returned.
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.
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 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary it was reported that the sterile package did not open up properly and therefore could not be safely passed off to the surgical field.The implant and its box were kept and will be returned.The product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found both the outer and inner packages opened.The inner sterile package exhibited adhesive remnants along the surfaces of the opened portion.Based on the observed condition of the inner seal and the pouch, it is reasonable to conclude that it may have been a difficulty to correctly open the sterile package.Although the packaging was returned in an open condition, available evidence suggests that the device had been correctly sealed and packaged by the manufacturer prior to being opened.There is no indication of a manufacturing error that could have contributed to the reported allegation.However, without further information, a definitive root cause cannot be determined.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional test was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the pinn can bone screw 6.5mmx50mm would have contributed to the complained device 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 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 packaging manufacturing record evaluation was performed for the finished device product description: pinn can bone screw 6.5mmx50mm product code: 121750500 lot number: d21112054 and no non-conformances or manufacturing irregularities were identified.

• Brand Name: PINN CAN BONE SCREW 6.5MMX50MM
• Common Device Name: BONE SCREWS AND PINS : SCREWS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JJM (SUZHOU) LTD. 3006356043; no.299 changyang st; suzhou industrial park; suzhou jiangsu 21512 -6; CH 21512-6
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 20020374
• Report Number: 1818910-2024-17747
• Device Sequence Number: 8601425
• Product Code: LPH
• UDI-Device Identifier: 10603295010418
• UDI-Public: (01)10603295010418(17)321031(10)D21112054
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K983014
• 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
• Report Date (Section B): 08/21/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 121750500
• Device Lot Number: D21112054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2024
• Supplement Date Received by Manufacturer: 08/27/2024; 10/07/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 08/28/2024; 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2022
• 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: Unknown