MAUDE Adverse Event Report: STRYKER GMBH CP REAMER AXSOS 3 AF 16MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	705803
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	09/04/2020
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.Still being used at hospital.
Event or Problem Description
Surgeon performed a tibio-talar joint fusion with use of an anterior cp plate.His feedback included the following: ¿cp reamer is a little large with anterior cortex and we broke it out but cp plate still worked.Just something to watch out for.¿ [provided as a comment on any dissatisfaction with the products and procedure] ¿cp reamer is very large.¿ [indicated as an identified area for improvement]."cp reamer.¿ [reported as an observed deficiency and/or complication].Additional information from sales representative: "[.] you have to ream down a good amount and in my case the cortex wasn¿t large enough to accept this depth cause the reamer to go into the canal.No delay and we still completed the case as desired.".

• Brand Name: CP REAMER AXSOS 3 AF 16MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10649526
• Report Number: 0008031020-2020-02294
• Device Sequence Number: 19487483
• Product Code: LXH
• UDI-Device Identifier: 07613327409628
• UDI-Public: 07613327409628
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• 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
• Report Date (Section B): 10/08/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 705803
• Device Catalogue Number: 705803
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/11/2020
• Initial Report FDA Received Date: 10/08/2020
• 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