MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH WAGNER SL REVISION, TRIAL STEM, DISTAL, 15; HIP INSTRUMENT

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Mechanical Problem (1384); Mechanical Jam (2983)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: wagner sl revision, screw for trial stem, l 225; catalog#: 01.00109.805; lot#: unknown hexagonal wrench, 3.5 mm; catalog#: 791584; lot#: 14967160 wagner sl revision, trial stem, proximal, l 190; catalog#: 01.00109.810; lot#: 14013306 wagner sl revision hip stem, uncemented, 15/190, taper 12/14; catalog#: 01.00101.915; lot#: 2923798 biolox delta, ceramic femoral head, m, 36/0, taper 12/14; catalog#: 00-8775-036-02; lot#: 3052997.Therapy date: unknown.The manufacturer received other source documents for review.The manufacturer received 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 a surgery, the threaded piece got stuck in the stem trial and the handle fractured when the surgeon tried to remove it.The surgery was completed with a second set of instruments.Note: the implantation and explantation dates are left empty as the device involved in this complaint is an instrument.Hence, no expiration date is captured, for the same reason.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected and additional information.Additional: d9, h2, h6.Correction: b4, g3, g6, h10.Event description: it was reported that during surgery the wagner trial stem could no longer be disassembled and the tip of the hexagonal wrench broke.The surgery was completed with a second set of instruments.No parts remained in the patient and there was no surgical delay.Review of received data: - no medical data relevant to the case has been received.- 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 assembled sl trial stem, consisting of the distal and proximal trial stems and the screw connecting both stems, as well as the hexagonal wrench were returned for examination.The hexagonal wrench has a broken off tip, which was not returned.The edges of the hexagonal screw head visible at the proximal end of the assembled trial stem are deformed and abraded.The screw can no longer be removed, making it impossible to disassemble the proximal and distal stems.The distal and proximal stems are inconspicuous.Review of product documentation: - device purpose: all involved devices are intended for treatment.- product compatibility: it was reported that a screw for a proximal trial stem of length 225 was used together with a proximal trial stem of length 190.According to the ordering information and the surgical technique for the wagner sl revision hip stem system this product combination is not approved by zimmer biomet, as the screw length must match with the length of the proximal trial stem.- dhr review: review of the device history records, of the devices with known lot number, identified no deviations or anomalies during manufacturing.Conclusion: it was reported that during surgery the wagner trial stem could no longer be disassembled and the tip of the hexagonal wrench broke.The surgery was completed with a second set of instruments.No parts remained in the patient and there was no surgical delay.The quality records of the devices with known lot number show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).Based on the investigation the most likely cause of the screw jamming in the trial stem is the unequal size of the 225 screw and the 190 proximal trial stem.Due to the longer screw, the upper and lower threads of the screw simultaneously screw into the threads of the proximal and distal trial stem, causing jamming.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 change to previously reported event.

• Brand Name: WAGNER SL REVISION, TRIAL STEM, DISTAL, 15
• Common Device Name: HIP INSTRUMENT
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 12251491
• Report Number: 0009613350-2021-00361
• Device Sequence Number: 17103611
• Product Code: LXH
• UDI-Device Identifier: 00889024277816
• UDI-Public: 00889024277816
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2021

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 Model Number: N/A
• Device Catalogue Number: 01.00109.115
• Device Lot Number: 14944222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/01/2021
• Supplement Date Received by Manufacturer: 09/17/2021
• Initial Report FDA Received Date: 07/30/2021
• Supplement Report FDA Received Date: 09/22/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization