MAUDE Adverse Event Report: STRYKER TRAUMA KIEL BONE PLUG EXTRACTOR T2 ICF; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	2358-3200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was not returned.If additional information becomes available it will be provided in a supplemental report.Device disposition unknown.
Event or Problem Description
Surgeon treated a chronic charcot foot in a both columns procedure on a patient that had previously been treated with an external fixator.His feedback included the following: "the 1st met bone plug we removed was too large.I think prior to re-inserting you should measure the depth + cut to size.Trying to tamp the large plug back in destroyed the cartilage of the joint.¿ [provided as a comment on any dissatisfaction with the products and procedure].

• Brand Name: BONE PLUG EXTRACTOR T2 ICF
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 10550775
• Report Number: 0009610622-2020-00527
• Device Sequence Number: 3345323
• Product Code: LXH
• UDI-Device Identifier: 07613327346466
• UDI-Public: 07613327346466
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 09/17/2020

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: 2358-3200
• Device Catalogue Number: 23583200
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/21/2020
• Initial Report FDA Received Date: 09/17/2020
• 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