MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH NCB, CORTICAL SCREW, 5.0 MM, 34 MM; NCB PLATING SYSTEM, PROXIMAL TIBIA PLATES

Model Number	N/A
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer received other source documents for review.The manufacturer did not receive the device for investigation.Where lot numbers were received for the devices, the device history records 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 biomet¿s reference number of this file is (b)(4).
Event or Problem Description
During surgery, the nurse found that there was a hole in the sterile packaging.The surgery was completed with another device.No information has been received regarding the surgical delay.
Additional Manufacturer Narrative
Investigation results were made available.Review of event description: it was reported that during surgery the nurse found a hole in the sterile packaging.The surgery was completed with another device.Review of received data: due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.Product evaluation: visual examination: the product with the complete packaging was returned.The visual examination confirms the reported event.The outer cardboard box (pvp) is open and the flap for rip open the box is completely removed (ripped off).The shrink foil is missing.The outer sterile packaging (avp) is also open.There is a hole in that outer sterile bag.The hole is only on one side.On the opposite corresponding side of the hole there is nothing conspicuous.The inner sterile bag (ivp) is intact.There is a small imprint on that inner bag (outside the vacuum seal area).Review of product documentation: device purpose: this device is intended for treatment.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Additional product documentation: before boxing (einschachteln pvp) the product is 100% visually inspected.Conclusion: it was reported that during surgery the nurse found a hole in the sterile packaging.The surgery was completed with another device.Based on the investigation the reported event can be confirmed.The complaint history of the item # 02.02150.034 shows that a similar event has never been reported.It can be considered as single case.Before boxing (einschachteln pvp) the products of the lot 3014975 were 100% visually inspected.Therefore, most likely such an issue should have been detected and potentially was caused outside zb control.However, based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.The investigation did not identify a nonconformance or a complaint out of box (coob).The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).
Event or Problem Description
No event update.Investigation results are now available.

• Brand Name: NCB, CORTICAL SCREW, 5.0 MM, 34 MM
• Common Device Name: NCB PLATING SYSTEM, PROXIMAL TIBIA PLATES
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 10740582
• Report Number: 0009613350-2020-00510
• Device Sequence Number: 1088375
• Product Code: HRS
• UDI-Device Identifier: 00889024290990
• UDI-Public: 00889024290990
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K061211
• 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): 01/20/2021

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: 11/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 02.02150.034
• Device Lot Number: 3014975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/14/2020
• Supplement Date Received by Manufacturer: 01/18/2021
• Initial Report FDA Received Date: 10/27/2020
• Supplement Report FDA Received Date: 01/20/2021
• 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
• Outcome Attributed to Adverse Event: Hospitalization