MAUDE Adverse Event Report: STRYKER GMBH 1.2X10MM BONE SCREWS,CROSS-PIN,SELF-T; PLATE, FIXATION, BONE

Catalog Number	58-12010
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event 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 as well as the affected device must be available in order to determine the exact root cause of the complaint event.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.Labelling review: the instruction for use was reviewed: ''screws should not be over-tightened during insertion.Excessive over-tightening will compromise the integrity of the screw head, result in possible screw breakage, and lead to loss of friction fit performance.'' part disposed, part left in patient.
Event or Problem Description
Primary hand procedure.It was reported that after achieving bi-cortical fixation of the patient's finger, the head of the screw broke off as the surgeon attempted to give it an additional turn.The screw head was removed and disposed in the sharps container, the implanted threaded portion was left in the bone.A second screw was implanted (surgeon did not report this was a result of the first screw breaking) and the procedure was completed successfully with no delay.Surgeon reported that he is satisfied with the completion of the procedure.Rep confirmed that no further information is available.

• Brand Name: 1.2X10MM BONE SCREWS,CROSS-PIN,SELF-T
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9372372
• Report Number: 0008031020-2019-01892
• Device Sequence Number: 2866818
• Product Code: HRS
• UDI-Device Identifier: 37613154583233
• UDI-Public: 37613154583233
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K062498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/25/2019

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: Health Professional
• Device Catalogue Number: 58-12010
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2019
• Initial Report FDA Received Date: 11/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR