MAUDE Adverse Event Report: ZIMMER GMBH WAGNER SL REVISION, SCREW FOR TRIAL STEM, L 225; WAGNER SL REVISION TRIAL STEM SCREW L 225

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	03/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This product is manufactured by zimmer biomet (b)(4) and is cleared for u.S.Distribution under exempt.The manufacturer did not receive the device yet, however it is indicated by complainant that it will be returned for investigation.The manufacturer did not receive x-rays, or other source documents for review.Device history record (dhr) review could not be performed as the lot number of the device here reported is unknown.The following report is associated with this event: 0009613350-2019-00252.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 when surgeon tried to remove the stem trial after finishing trial-reduction, the screw broke inside the distal trial, and made it impossible to retrieve the distal trial from the canal.An osteotomy had to be performed to take out the instrument.Attempts to obtain additional information have been made; however, no more is available.

• Brand Name: WAGNER SL REVISION, SCREW FOR TRIAL STEM, L 225
• Common Device Name: WAGNER SL REVISION TRIAL STEM SCREW L 225
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8548700
• Report Number: 0009613350-2019-00253
• Device Sequence Number: 16236534
• Product Code: LXH
• UDI-Device Identifier: 00889024277960
• UDI-Public: 00889024277960
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: SEE H10
• 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
• Report Date (Section B): 04/25/2019

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 01.00109.805
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2019
• Initial Report FDA Received Date: 04/25/2019
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention