MAUDE Adverse Event Report: STRYKER GMBH MINI 2.5MM HEADED SCREW LENGTH 16MM; SCREW, FIXATION, BONE

Model Number	IC2516
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
As reported: "i started working with this high volume dpm about 3 months ago.It was brought to my attention that 2 maybe 3 revisions are needed now on a chevron osteotomy that the surgeon used our mini cannulated 2.5 headed screws.Reported that some of the screws have broken.".
Event or Problem Description
Started working with this high volume dpm about 3 months ago.It was brought to my attention that 2 maybe 3 revisions are needed now on a chevron osteotomy that the surgeon used our mini cannulated 2.5 headed screws.Reported that some of the screws have broken.Per info received from rep: there was a miss communication between the director and the surgeon regarding these screws.Director thought the screws were breaking but after looking into this more this was not true.I reported what was told to me from the director and after looking into it further with the surgeon the screws were not breaking.I'm sorry for the inconvenience.Per information received from the sales force january 14 2021: no screws were broken and no revisions were to be made.Miscommunication between the director of the hospital and the surgeon.This can be canceled.
Additional Manufacturer Narrative
Based on information received from the stryker sales representative on january 14 2021: no screws were broken and no revisions were to be made.Miscommunication between the director of the hospital and the surgeon and therefore this event can be canceled out.If additional information become available, this investigation will be reopened.

• Brand Name: MINI 2.5MM HEADED SCREW LENGTH 16MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11168091
• Report Number: 0008031020-2021-00023
• Device Sequence Number: 3583093
• Product Code: HWC
• UDI-Device Identifier: 07613327362091
• UDI-Public: 07613327362091
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K120493
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2021

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: Lay User/Patient
• Device Model Number: IC2516
• Device Catalogue Number: IC2516
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/18/2020
• Supplement Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 01/18/2021
• 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: Required Intervention