MAUDE Adverse Event Report: ZIMMER GMBH INVERSE/REVERSE SCREW SYSTEM, 4.5-36; ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM

Model Number N/A

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/02/2016

Event Type  malfunction  

Manufacturer Narrative

The manufacturer did not yet receive the device and packaging, but it is mentioned by complainant that it will be returned for investigation.Where lot numbers were received for the device, the device history record were reviewed and found to be conforming.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.Zimmer's reference number of this file is (b)(4).

Event Description

It is reported that the external package of the device was intact, but the internal packaging containing screw and cap, was open and the cap was dropped.No impact to a person was reported, the product was replaced.

Manufacturer Narrative

Dhr review results: dhr records were reviewed and found to be conforming.Trend analysis: no trend identified.Event summary: it was reported that the outer package was found to be intact but the inner package was open and that the cap screw drop out from the inner package.Review of received data: one picture of the inner and of the outer package with screw and cap was returned.The outer package was open and therefore it is impossible to confirm that it was intact before opening.The inner package is clearly open and not in vacuum anymore.The opening is visible at the right side of the seal and is not transparent anymore but opaque.The opening of the inner package is located close to the two flaps usually used to open the package during surgery.Devices analysis: visual examination: the visual examination confirms what already observed in the received photo.Root cause analysis, dfmea: package is not seal due to bar code scanner is not working and the user manually entered wrong program.Possible: possible human error during visual examination.Package is not sealed due to uncareful manipulation of seal parameters (pressure, time, temperature).Possible: possible human error.Package is not seal due to wrong bag used.Not possible: blister according to specification.Bag is damaged due to uncareful manipulation while positioning product in the bag.Not possible: positioned correctly.Bag is damaged due to production error during bag manufacturing.Not possible: the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Seal not according to specifications due to packaging not performed according process when positioning bag for sealing in sealing machine.Possible: it is possible that material was left between the two layers before seal.Conclusion summary: the inner package was reported to be open and the outer package to be intact.However, the seal of the inner package has been clearly opened as the surface is whitish-opaque (not transparent anymore).Moreover, the outer package is completely open.It is highly probable that during the opening of the outer package, the inner package stuck to the outer and opened as well.It is also possible that during uncareful opening of the inner package, the cap screw fell out and the surgeon decided to proceed with a new package.However, an exact root cause could not be determined.The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed.(b)(4).

• Brand Name: INVERSE/REVERSE SCREW SYSTEM, 4.5-36
• Type of Device: ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM
• Manufacturer (Section D): ZIMMER GMBH; sulzerallee 8; winterthur, 8404 ; SZ 8404
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 5742676131
• MDR Report Key: 5433369
• MDR Text Key: 38745928
• Report Number: 9613350-2016-00236
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 01.04223.036
• Device Lot Number: 2801089
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1