MAUDE Adverse Event Report: ZIMMER GMBH WAGNER SL REVISION, TRIAL STEM, DISTAL, 15; 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) was reviewed and no discrepancies were found.The following report is associated with this event: 0009613350-2019-00253.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.
Event or Problem Description
Please refer to report 0009613350-2019-00252.
Additional Manufacturer Narrative
This follow-up report is being filled to relay investigation result.Dhr review: screw: the dhr check could not be performed as the lot number was not available.Trial stem: the dhr check confirmed that the product met all specifications to perform as intended.Trend analysis: no trend considering the following event is identified: jammed.No trend considering the following event is identified: fracture.Event description: it was reported that during a revision surgery on (b)(6) 2019 when surgeon tried to remove the stem trial after finishing trial-reduction, the screw broke inside the distal trial, and the surgeon could not retrieve the trial stem from the canal.The surgeon had to do osteotomy to open the bone to take out the instrument.There was no surgical delay in excess of 30min.Review of received data: no medical data provided due to country regulations.Device analysis: visual examination: a wagner sl trial stem d15 (ref 01.00109.115 lot 12.802373) with a broken wagner sl screw l225mm (ref 01.00109.805, lot not able to observe because stuck in distal stem) has been received.The wagner sl trial stem d16 shows some minor scratched, especially on the flanks in the proximal part.Further visual examination shows brakeage of the screw inside the trial stem.Visual examination on the screw shows that the screw broke in the groove just above the thread for the distal stem.Further visual examination of the screw shows that the hexagonal socket of the screw shows signs of usage.Based on this visual examination the reported event can be confirmed.Measurements: wagner sl trial stem d16: to ensure the wagner sl trial stem d15 has correct dimensions, relevant characteristics according to inspection plan and product drawing were measured with caliper so 2083.Characteristic no.2 feature aussen ø cross section c-c, specification: max.15.2 mm; min.14.9 mm, measured value: 15.08 mm.Conclusion: the characteristic of the wagner sl trial stem d15 is within specification.Screw: to ensure the wagner sl screw has correct dimensions, relevant characteristics according to inspection plan and drawing were measured with caliper so 2083.Characteristic no.16 feature dimension ( 7.5 0/-0.5 ), specification: max.7.5 mm; min.7 mm, measured value: 7.47 mm, conclusion: the characteristic of the wagner sl screws is within specification.Measurements show that the screw broke 14.75mm from the distal end and therefore support the results from visual examination that the screw broke in the groove next to the distal thread.Review of product documentation: all involved devices are intended for treatment.Compatibility: compatibility check could not be performed as the product identification is given for the distal trial stem only.The screw used here for proximal trial stem l225 (ref: 01.00109.805) must be used with the proximal trial stem of length 225 (ref: 01.00109.802).As the product identifications of the proximal trial stem are unknown we cannot confirm the compatibility of the used instruments.Wagner sl trial stem: inspection plan: characteristic no.2 feature aussen ø with scope of testing 100%.Means of inspection: caliper.Screw: inspection plan: characteristic no.16 feature dimension ( 7.5 0/-0.5 ) with scope of testing aql 3.Means of inspection: caliper.Ordering information : the screws for proximal trial stems are size dependent.For instance, the screw for the proximal trial stem l225 (ref: 01.00109.805) must be used with the proximal trial stem of length 225 (ref: 01.00109.802) only.Conclusion: based on the returned product and the given information the complaint could be confirmed.The visual examination did confirm that the screw has fractured off and is stuck inside the distal stem.The scratches in the distal stem are introduced during osteotomy and removal of the distal stem.The quality records of the distal stem and the screws show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.As the proximal trial stem has neither been received nor reported, it is possible that the wrong combination of screw and proximal stem was used.Further, it may be possible that an incorrect assembly of the instruments may have led to too high loads or bending stresses, causing the screw to break.In conclusion, based on the investigation and the missing device identification of the proximal trial stem, we were not able to identify a specific root cause for the reported event.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: WAGNER SL REVISION, TRIAL STEM, DISTAL, 15
• 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: 8548694
• Report Number: 0009613350-2019-00252
• Device Sequence Number: 16577041
• Product Code: LXH
• UDI-Device Identifier: 00889024277816
• UDI-Public: 00889024277816
• 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,Followup
• Report Date (Section B): 08/22/2019

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: 01.00109.115
• Device Lot Number: 12.802373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/27/2019
• Supplement Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 04/25/2019
• Supplement Report FDA Received Date: 08/22/2019
• 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