MAUDE Adverse Event Report: STRYKER GMBH RECTANGULAR PLATE, SIZE 1; PLATE, FIXATION, BONE

Model Number	40-15031
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
At the plate hole 40-15031 the screw (b)(4) falls through.Replacement was available.Surgical delay of 20 minutes not longer.No other consequences reported.
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: the returned plate is completely damaged / bent.The oblong screw hole is damaged / deformed to such an extend that the screw does fall through as reported.The plate is completely deformed, no bending marks of a plate bender are visible.The damaged / deformity observed; concludes that far too much mechanical force during screw insertion had been applied.A close up of the badly damaged t10 screw interface also confirms this.Possible inadequate screw positioning did not result in the planed compression.A review of the device history for the reported lot did not indicate any abnormalities.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 be user related.The failure was caused by too much mechanical force during screw insertion (over torqued).If any further information is provided, the investigation report will be updated.
Event or Problem Description
At the plate hole 40-15031 the screw 657440 falls through.Replacement was available.Surgical delay of 20 minutes not longer.No other consequences reported.

• Brand Name: RECTANGULAR PLATE, SIZE 1
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9584504
• Report Number: 0008031020-2020-00101
• Device Sequence Number: 3012223
• Product Code: HRS
• UDI-Device Identifier: 07613154627868
• UDI-Public: 07613154627868
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K063875
• 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): 03/03/2020

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: 40-15031
• Device Catalogue Number: 40-15031
• Device Lot Number: 1000366853
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2020
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 01/13/2020
• Supplement Report FDA Received Date: 03/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1