MAUDE Adverse Event Report: STRYKER GMBH CANCELLOUS SCREW AXSOS 3 TI Ø4.0MM / L28MM / FULL THREAD; PLATE, FIXATION, BONE

Catalog Number	607328
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event that cancellous screw axsos 3 ti ø4.0mm / l28mm / full thread was alleged of 'breakage during surgery' could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event such as the lot numbers of the reported product as well as the affected device must be available in order to determine the root cause of the complaint event.Indeed, with the provided information, it is unclear how or where the device broke.A review of the device history was not possible because the lot number was not communicated.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
The pharmacist from the hospital reported to the sales rep, the following event: osteosynthesis right humerus fracture/plate placement 3 spongy screws broke and then a cortical screw during installation.It was spongy screw diameter 4 ref 607322 /607324/607328 a locking screw also broke during installation ref 661034.No consequence for the patient: slightly increased operating time.

• Brand Name: CANCELLOUS SCREW AXSOS 3 TI Ø4.0MM / L28MM / FULL THREAD
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8324473
• Report Number: 0008031020-2019-00060
• Device Sequence Number: 2284266
• Product Code: HRS
• UDI-Device Identifier: 07613252578529
• UDI-Public: 07613252578529
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K181091
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 02/09/2019

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: Lay User/Patient
• Device Catalogue Number: 607328
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2019
• Initial Report FDA Received Date: 02/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other