MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SPECIALTY THREADED FIXATION PIN 1.86 IN.; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	I-K2218FP00
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An event regarding crack/fracture involving a specialty pin was reported.The event was not confirmed.Device evaluation and results: not performed as product was not returned.Clinician review: no medical records were received for review with a clinical consultant .Device history review: could not be performed as lot code information was not provided.  complaint history review: could not be performed as lot code information was not provided.  conclusion: the event could not be confirmed because insufficient information was provided.Additional information including operative reports, device lot identification, return of the device as well as photographs/video of the event as it occurred are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
Part #: i-k2218fp00 2 pins were used in a total knee.They were drilled into the patient using a wire driver and upon removing the wire driver the end of the pins broke off.Nothing was left in the patient.

• Brand Name: SPECIALTY THREADED FIXATION PIN 1.86 IN.
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 11389375
• Report Number: 0002249697-2021-00351
• Device Sequence Number: 11793488
• Product Code: LXH
• UDI-Device Identifier: 07613327316223
• UDI-Public: 07613327316223
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/26/2021

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: I-K2218FP00
• Device Catalogue Number: I-K2218FP00
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 02/26/2021
• 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: Other