MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN SECTOR W/GRIPTION 60MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number 121732060

Device Problems Device Contaminated During Manufacture or Shipping (2969); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 03/04/2024

Event Type  malfunction  

Event Description

It was reported that the surgeon reamed for a 60 cups.Scrub nurse unwrapped the shrink wrap of the pinnacle gription sector 60mm cup opened the box.Tried to peel back the first 'peel here' paper to expose the sterile container with cup and the paper was not sealed.The second 'peel here' tab was also not sealed.The cup inside had etching "do not implant' was surgery delayed due to the reported event? unknown.

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.

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.H10 additional narrative: corrected: d4 (lot, expiration date), h4 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 : surgeon reamed for a 60 cups.Scrub nurse unwrapped the shrink wrap of the pinnacle gription sector 60mm cup (consignment stock) opened the box.Tried to peel back the first 'peel here' paper to expose the sterile container with cup and the paper was not sealed.The second 'peel here' tab was also not sealed.The cup inside had etching "do not implant' the product was returned to depuy synthes for evaluation.The depuy synthes team forwarded the device to depuy cork which conducted a visual inspection of the returned device.The complaint unit was returned to depuy cork for review.Photographs of the device were provided by the customer.The investigation performed revealed there is an etching "do not implant" on the device associated with this complaint, however the investigation found that it didn't happened during the manufacturing process.It is unknown where the etching may have occurred, however it is suspected it may have occurred after distribution.Both the first and second 'peel here' tabs and barriers were not sealed prior to their time of intended use, however with the information provided is not possible to determine when the event occurred since this cannot be traced to a manufacturing issue.Therefore a potential impact on the sterility of the unit / on the integrity of the sterile barrier based on the complaint investigation was identified, as the packaging was already opened prior to its intended time of use.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the pinn sector w/gription 60mm would contribute 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 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 : a review was completed of the device history record (dhr) for the finished device 121732060/8953425 was manufactured on 08-nov-2018.(b)(4) parts were manufactured to specification.

• Brand Name: PINN SECTOR W/GRIPTION 60MM
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): LEEDS MFG & MATERIAL WAREHOUSE; st anthonys road; leeds
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18877379
• MDR Text Key: 337548694
• Report Number: 1818910-2024-05547
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295010340
• UDI-Public: 10603295010340
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K093646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/11/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 121732060
• Device Lot Number: 8953425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/04/2024
• Initial Date FDA Received: 03/11/2024
• Supplement Dates Manufacturer Received: 03/12/2024; 05/24/2024
• Supplement Dates FDA Received: 03/14/2024; 05/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1