MAUDE Adverse Event Report: ZIMMER GMBH DURASUL, ALPHA INSERT, GG/32; INTER-OP DURASUL ACETABULAR INSERTS/COCR FEMORAL HEADS

Model Number N/A

Device Problem Device Packaging Compromised (2916)

Patient Problem No Information (3190)

Event Date 11/22/2017

Event Type  malfunction  

Manufacturer Narrative

The packaging of the device was received, the investigation is pending.The device history records were reviewed and found to be conforming.Additional information has been requested and is currently not available.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.(b)(4).

Event Description

It was reported that during a surgery on (b)(6) 2017 a bag had to be cut open with scissors in order to extract the implant.The sterile bag was sealed with the unsterile bag.This could possibly cause contamination of the implant if it were to recur.

Manufacturer Narrative

Investigation results were made available.Additional: a1, h2.Correction: b4, g4, g7, h3, h6, h10.Dhr-review: the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trend considering the following event is identified: inner bag sealed with outer bag event description: it was reported that sterile bag was sealed with the unsterile bag.The bag had to be cut open with scissors in order to extract the implant.Review of received data: no other case-relevant documents received.Devices analysis: - the visual examination confirms that the sterile bag (ivp) is sealed with the outer bag (avp).A part of around 2 - 4mm of the ivp is sealed together with the avp.- it can be confirmed that the inner sterile bag (ivp) cannot be removed as intended from the outer bag (avp).Review of product documentation: - in the applicable work instruction document the following is written: "falte den ivp so, dass er etwa in der mitte der avp-beutelverpackung liegt." this step was not conducted properly.Conclusion summary: it was reported that sterile bag was sealed with the unsterile bag.The visual examination confirmed that the sterile bag (ivp) was sealed with the outer bag (avp) and could therefore not be removed as intended.According to the "applicable work-instruction", during packaging the inner bag should be put in the outer bag in a middle position.If this is not the case this kind of error pattern can happen in rare cases.The most likely root cause is a manufacturing issue during packing the product in the finish.The need for remedial actions is not indicated at this point of time and zimmer gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).

• Brand Name: DURASUL, ALPHA INSERT, GG/32
• Type of Device: INTER-OP DURASUL ACETABULAR INSERTS/COCR FEMORAL HEADS
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 7133818
• MDR Text Key: 95383821
• Report Number: 0009613350-2017-01756
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: PK993259
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 09/05/2018

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 Expiration Date: 08/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 01.00013.407
• Device Lot Number: 2917134
• Other Device ID Number: 00889024413597
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2017
• Initial Date Manufacturer Received: 11/22/2017
• Initial Date FDA Received: 12/20/2017
• Supplement Dates Manufacturer Received: 08/08/2018
• Supplement Dates FDA Received: 09/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1