MAUDE Adverse Event Report: STRYKER GMBH PLATE ADAPTER DIST. LAT. FEMUR RIGHT; PLATE, FIXATION, BONE

Catalog Number	703522
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	09/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported by rep: "case type: right distal femoral periprosthetic fracture.Prh-telford had item: 703522 (plate adapter / dist lat right) break." further information from rep on 09/27/2024: "when attaching adaptor to plate, one of the ¿teeth¿ had sheared off rendering the device unstable and therefore unusable.Attempted minimally invasive technique in compromised patient; however, once the adaptor broke, the surgeon had to make a large incision to attach the plate to the bone.Debris reported.Instrument broke away from the patient.Large wound in compromised patient.
Event or Problem Description
As reported by rep: "case type: right distal femoral periprosthetic fracture.Prh-telford had item: 703522 (plate adapter / dist lat right) break.".Further information from rep on 09/27/2024: "when attaching adaptor to plate, one of the ¿teeth¿ had sheared off rendering the device unstable and therefore unusable.Attempted minimally invasive technique in compromised patient; however, once the adaptor broke, the surgeon had to make a large incision to attach the plate to the bone.Debris reported.Instrument broke away from the patient.Large wound in compromised patient.
Additional Manufacturer Narrative
The reported event could be confirmed, since one of the teeth has broken off as described in the event description.The device inspection revealed the following: the plate adapter was returned for investigation.One of the three alignment teeth at the plate interface is broken off as complained, the fragment was not returned for investigation.The visual inspection of the plate interface has shown that the smaller tooth on the thinner side of the housing is broken off.The larger teeth are slightly worn but otherwise intact.The microscopic inspection of the fracture face did show the typical view of a brittle overload fracture.The fracture face is homogeneous which indicates material conformity.In general, is the device in a used condition, the laser markings are faded and there are wear marks all over the device visible.Furthermore, a hardness test according to rockwell on the returned item indicates the material being in accordance with the values in the material specification.A review of the device history for the reported lot did not indicate any abnormalities.The device in question was manufactured in the year 2014 and we are not aware of any other complaint for this lot number.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.Based on investigation, the root cause was attributed to a user related issue as no product related issue could be detected.The event was most likely caused by applying too much lateral force onto the plate interface without having the plate adapter fully tightened.By this the force was only distributed on the most fragile tooth at the thinner side of the housing, which did lead to a mechanical overload.If more information is provided, the case will be reassessed.

• Brand Name: PLATE ADAPTER DIST. LAT. FEMUR RIGHT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20536863
• Report Number: 0008031020-2024-00607
• Device Sequence Number: 6682210
• Product Code: HRS
• UDI-Device Identifier: 04546540693600
• UDI-Public: 04546540693600
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K200398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2025

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 Catalogue Number: 703522
• Device Lot Number: K09EF8A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/27/2024
• Supplement Date Received by Manufacturer: 12/19/2024
• Initial Report FDA Received Date: 10/25/2024
• Supplement Report FDA Received Date: 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2014
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown