MAUDE Adverse Event Report: ZIMMER GMBH HUMERAL STEM UNCMNTD 14-100; ANATOMICAL SHOULDER SYSTEM/ANATOMICAL SHOULDER DOMELOCK SYSTEM/ANATOMICAL SHOULD

Model Number	N/A
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Photographs were received and will be reviewed as part of ongoing investigation.The manufacturer did not receive the device yet, however it is indicated by complainant that it will be returned for investigation.The device manufacturing quality records indicate that the released components met all requirements to perform as intended.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 or Problem Description
It was reported that during surgery a packaging of as humeral stem was opened and it was found out that the sterile packaging was compromised.Another implant of the same ref.Was opened and used.Note: device was not used.(not implanted) therefore no implantation/explantation date given.
Additional Manufacturer Narrative
Dhr-review: ref#: 01.04201.143, lot#: 2871587.Yield: 17, delivered: 17.The device manufacturing quality records have been checked and indicate that the released components met all requirements to perform as intended.Trend analysis: no trigger considering the following event is identified: packaging : damaged sterile packaging event description: it was reported that during surgery a packaging of as humeral stem was opened and it was found out that the sterile packaging was compromised.Review of received data: the received pictures confirm that the bags show a tear of around 2 cm exactly at the area where the bags are folded.No other conspicuousness visible.Devices analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: this device is intended for treatment.Lot 2871587 was manufactured on august 09, 2016.Conclusion summary: it was reported that during surgery a packaging of as humeral stem was opened and it was found out that the sterile packaging was compromised.The device manufacturing quality records have been checked and indicate that the released components met all requirements to perform as intended.No product/packaging has been returned to zimmer biomet for the investigation.However, the received pictures confirm that the bags show a tear of around 2 cm exactly at the area where the bags are folded.No other conspicuousness visible.The complaint history shows that no further similar event for lot 2871587 has ever been reported.Additionally no trend on lot or packaging configuration 45gp has been identified.Therefore the most likely root cause is a transport and/or handling issue.An abnormal force led to a damaged inner sterile bag.The investigation results did not identify a non-conformance.However, in the meantime in 2017 the packaging of this product family was revised due to a global packaging change.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).
Event or Problem Description
Investigation results are now available.

• Brand Name: HUMERAL STEM UNCMNTD 14-100
• Common Device Name: ANATOMICAL SHOULDER SYSTEM/ANATOMICAL SHOULDER DOMELOCK SYSTEM/ANATOMICAL SHOULD
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8614768
• Report Number: 0009613350-2019-00309
• Device Sequence Number: 13998300
• Product Code: KWS
• UDI-Device Identifier: 00889024484931
• UDI-Public: 00889024484931
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K142403
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2019

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 Expiration Date: 07/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 01.04201.143
• Device Lot Number: 2871587
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/03/2019
• Supplement Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 05/16/2019
• Supplement Report FDA Received Date: 08/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1