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

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: wagner sl revision, trial stem, proximal, l 225; item#01.00109.802; lot#4500618275.Wagner sl revision, trial stem, distal, 16; item#01.00109.116; lot#10.552992.The manufacturer did not receive x-rays 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.(b)(4).
Event or Problem Description
Event happened during the surgery when the proximal body trial fractured from the distal body trial.Locking screw was also fractured during the same event.It is unknown whether all the broken pieces were removed from patient.
Additional Manufacturer Narrative
This follow-up report is being filled to relay investigation result.Additional and corrected information are filled in the following fields: correction: b4 - g4 - g7 - h10.Trend analysis: no trend has been identified.Event description: during a revision surgery while trial stem extraction the locking screw fractured and led to the disassociation of the proximal trial component from the distal trial component.This resulted in an extensive trochanteric osteotomy of the femur in order to retrieve the distal trial component.It is unknown whether all broken pieces could be removed from patient.Review of received data: no medical data such as surgical notes or any other case-relevant documents received due to patient privacy policy.Device analysis: visual examination: the proximal trial stem component with half of the broken screw and the distal trial stem component with the other half of the broken screw have been returned for evaluation.For evaluation, the screw was disassembled from the proximal trial stem component.The proximal trial stem component shows extensive signs of usage consisting of scratches, indentations, discoloration and a faded laser labeling, pointing to wear and tear from repeated usage.The distal trial stem component has highly deformed flanks and surface structures as well as a bore hole from the performed osteotomy, which was necessary in order to retrieve the stuck distal component from the patient's femur.On the deformed surfaces also corrosion can be found, which most likely developed after the event due to the surface damage.One half of the trial screw is stuck inside the distal trial component and cannot be retrieved.The other half of the screw could be retrieved from the proximal trial component.The retrieved screw is labeled with 225.Based on this visual examination the reported event can be confirmed.Review of product documentation: all involved devices are intended for treatment.The product combination was approved by zimmer biomet.Dhr review: the quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.Conclusion: during a revision surgery while trial stem extraction the locking screw fractured and led to the disassociation of the proximal trial component from the distal trial component.This resulted in an extensive trochanteric osteotomy of the femur in order to retrieve the distal trial component.It is unknown whether all broken pieces could be removed from patient.The proximal trial stem component with half of the broken screw and the distal trial stem component with the other half of the broken screw have been returned for evaluation.The disassembly of the fractured screw from the proximal trial component showed that the correct screw size has been used during assembly.The distal trial component shows extensive damages and deformations, which can be attributed to the required osteotomy in order to retrieve the stuck distal component from the patient's femur.Based on the visual examination the reported event can be confirmed.The complained components are compatible.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation results did not identify a non-conformance or a complaint out of box (coob).The complained parts were manufactured in 2011.Further, the visual examination showed that the parts have signs of wear and tear.Especially the screw head is worn, which points to an overtightening of the screw.In conclusion, it is possible that the distal screw thread got jammed and in combination with the overtorque led to the fracture of the screw.Nevertheless, an exact root cause could not be identified.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).
Event or Problem Description
Please refer to report 0009613350-2019-00725.

• Brand Name: WAGNER SL REVISION, SCREW FOR TRIAL STEM, L 225
• Common Device Name: WAGNER SL REVISION, SCREW FOR TRIAL STEM, L 225
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9390045
• Report Number: 0009613350-2019-00725
• Device Sequence Number: 16749985
• Product Code: KWA
• UDI-Device Identifier: 00889024277960
• UDI-Public: 00889024277960
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/01/2019
• Supplement Date Received by Manufacturer: 03/13/2020
• Initial Report FDA Received Date: 11/28/2019
• Supplement Report FDA Received Date: 03/16/2020
• 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