MAUDE Adverse Event Report: ZIMMER GMBH ZNN CMN LAG SCREW 10.5 MM, 90 MM, INCLUDING SET SCREW

Model Number	N/A
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive yet the device, however it is indicated by complainant that it will be returned for investigation.As no lot number was provided, the device history records could not be reviewed.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.Zimmer biomet¿s reference number of this file is (b)(4).
Event or Problem Description
It was reported that two znn lag screw got damaged during the surgery resulting in 40 minutes delay of surgery.
Event or Problem Description
Please refer to report 0009613350-2018-01268.
Additional Manufacturer Narrative
This follow-up report is being filled to relay investigation result.Additional and corrected information are filled in the following fields: additional: d11 - e1 - h2 - h6; correction: b4 - g4 - g7 - h10.D11 - medical products and therapy date.Detail of product: - iten number 47248508510, item name znnâ, cmn lag screw,10.5 mm, 85 mm, including set screw, lot number unknown.Dhr review: the dhr check could not be performed as the lot number was not available.Trend analysis: no trigger considering the following event is identified: device damaged.Event description: during surgery on dec 4, 2018, two znn lag screw got damaged.The surgery was completed with 80 mm lag screw.The surgery was delayed by 40 minutes.Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents received.Device analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: - all involved devices are intended for treatment.- surgical technique: the correct lag screw placement is described on pages 14-21.Conclusion: during the surgery on (b)(6) 2018, two znn lag screws got damaged.The surgery was completed with an 80 mm lag screw.The dhr check could not be performed as the lot numbers were not available.No product was returned to zimmer biomet for in-depth analysis.It is not in detail explained in which surgical step, both lag screws were damaged.The used instrumentation is also not mentioned.The correct insertion/placement of the lag screw is described in the surgical technique 97-2493-002-00.The investigation results did not identify a non-conformance or a complaint out of box (coob).Based on the given information and the results of the investigation, the complaint could not be confirmed as the alleged failure could not be identified or reproduced.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).

• Brand Name: ZNN CMN LAG SCREW 10.5 MM, 90 MM, INCLUDING SET SCREW
• Common Device Name: ZNN CMN LAG SCREW
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8177932
• Report Number: 0009613350-2018-01268
• Device Sequence Number: 2024467
• Product Code: HSB
• UDI-Device Identifier: 00889024298439
• UDI-Public: 00889024298439
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K091566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 47-2485-090-10
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/05/2018
• Supplement Date Received by Manufacturer: 07/09/2019
• Initial Report FDA Received Date: 12/19/2018
• Supplement Report FDA Received Date: 07/10/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: REFER TO H10.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 73 YR