MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURER GMBH BLUNT TIP SCREW, 4X34MM; ROD, FIXATION, INTRAMEDULLARY

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/29/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Cmp-(b)(4).Foreign-(b)(6).Concomitant medical products: item#:47-2486-052-40 lot#:3076792 itemname#:ann blunt tip screw 4x52mm, item#:47-2486-124-40 lot#:3091457 itemname#:ann cort bone screw 4 x 24mm, item#:47-2486-124-40 lot#:3078235 itemname#:ann cort bone screw 4 x 24mm, item#:47-2488-000-04 lot#:3081960 itemname#:ann washer small, item#:47-2488-010-00 lot#:3091275 itemname#:affixus ph nl cap 0mm, item#:47-2486-036-40 lot#:3068458 itemname#:blunt tip screw, 4x36mm, item#:47-2486-034-40 lot#:3078217 itemname#:blunt tip screw, 4x34mm, item#:47-2496-161-09 lot#:3083154itemname#:proximal humerus, left, 9x160mm.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0009613350 -2022 -00497.0009613350 -2022 -00501.0009613350 -2022 -00502.
Event or Problem Description
It was reported that the screw backed out from its proper position two weeks after implantation.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay correction and additional information.As no product was returned, visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were not provided.Based on the available information it is not possible to determine the root cause for this issue.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: BLUNT TIP SCREW, 4X34MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 15492798
• Report Number: 0009613350-2022-00500
• Device Sequence Number: 11234099
• Product Code: HSB
• UDI-Device Identifier: 00889024505414
• UDI-Public: (01)00889024505414(17)260714(10)3077767
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K200814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2022

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 Expiration Date: 07/14/2026
• Device Model Number: N/A
• Device Catalogue Number: 47-2486-034-40
• Device Lot Number: 3077767
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2022
• Supplement Date Received by Manufacturer: 10/06/2022
• Initial Report FDA Received Date: 09/27/2022
• Supplement Report FDA Received Date: 10/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown