MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING DRILL SLEEVE, LONG IMN INSTRUMENTS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	23514280
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
The surgeon was doing a t2 alpha tibial nail.The black material sheered from the calibrated trocar (cat # 2351-4280), while assembly.
Additional Manufacturer Narrative
A physical examination was not performed since no product was returned.Received information revealed initial test was performed without observation of deficiencies.During instrument assembly in a case allegedly the black connection component broke apart ¿ a sent image confirmed material separation.Tests performed by stryker, partly with units from the same lot, could not reproduce the shown material separation without using undue force.Incoming inspection and the dhr of the reported sleeve revealed no manufacturing discrepancies.Review of rmf and nc-database revealed no findings.To date no further complaints regarding this matter have been filed.According to available information a systematic matter was not verified.The root cause could not be determined.Device disposition unknown.
Event or Problem Description
The surgeon was doing a t2 alpha tibial nail.The black material sheered from the calibrated trocar (cat # 2351-4280), while assembly.

• Brand Name: LOCKING DRILL SLEEVE, LONG IMN INSTRUMENTS
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 8283521
• Report Number: 0009610622-2019-00058
• Device Sequence Number: 2463232
• Product Code: LXH
• UDI-Device Identifier: 07613327368178
• UDI-Public: 07613327368178
• 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: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2019

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 Catalogue Number: 23514280
• Device Lot Number: KP423133
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/03/2019
• Supplement Date Received by Manufacturer: 04/04/2019
• Initial Report FDA Received Date: 01/28/2019
• Supplement Report FDA Received Date: 04/25/2019
• 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