MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SPECIALTY TRIATHLON PKR C-ARM TIBIAL IMPACTOR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	I-K2958TI00
Medical Device Problem Codes	Fracture (1260); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
The welded part at the tip of "i-k2958ti00" in the @ pkr-rm-ll instrument set was removed and it was inside the joint.It was discovered at the time of postoperative x-ray confirmation.A skin incision was made again and it was removed from the joint.There is no residue in the body.
Event or Problem Description
The welded part at the tip of "i-k2958ti00" in the at pkr-rm-ll instrument set was removed and it was inside the joint.It was discovered at the time of postoperative x-ray confirmation.A skin incision was made again and it was removed from the joint.There is no residue in the body.
Additional Manufacturer Narrative
Reported event an event regarding crack/fracture involving a specialty impactor was reported.The event was confirmed through material analysis of the returned device.Method & results product evaluation and results: visual inspection of the returned device noted the device was worn/damaged.Examination of the returned device with engineer indicated that the device is worn due to in service use.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Clinician review: no medical records were received for review with a clinical consultant.Product history review: indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: visual inspection of the returned device noted the device was worn/damaged.Examination of the returned device with engineer indicated that the device is worn due to in service use.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined no further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: SPECIALTY TRIATHLON PKR C-ARM TIBIAL IMPACTOR
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10677372
• Report Number: 0002249697-2020-02129
• Device Sequence Number: 3000103
• Product Code: LXH
• UDI-Device Identifier: 07613327258318
• UDI-Public: 07613327258318
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 03/03/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: I-K2958TI00
• Device Catalogue Number: I-K2958TI00
• Device Lot Number: AP9V09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Initial Date Received by Manufacturer: 09/16/2020
• Supplement Date Received by Manufacturer: 02/05/2021
• Initial Report FDA Received Date: 10/14/2020
• Supplement Report FDA Received Date: 03/03/2021
• 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