MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MONOGRAM TORQUE WRENCH; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	6633-9-986
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information has been requested and if received will be provided in a supplemental report.Not returned.
Event or Problem Description
Head of the first hexagonal key was broken during constructing prosthesis.Arch of the second key was broken during the same procedure.
Event or Problem Description
Head of the first hexagonal key was broken during constructing prosthesis.Arch of the second key was broken during the same procedure.
Additional Manufacturer Narrative
An event regarding fracture involving a monogram torque wrench was reported.The event was confirmed by device images.Conclusions: the reported fracture was confirmed however, the root cause could not be determined as the device was not returned for evaluation.If the device becomes available, this record will be reopened.

• Brand Name: MONOGRAM TORQUE WRENCH
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7588468
• Report Number: 0002249697-2018-01768
• Device Sequence Number: 19388622
• Product Code: LXH
• UDI-Device Identifier: 07613327258493
• UDI-Public: 07613327258493
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2018

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: 6633-9-986
• Device Lot Number: S11H03
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/16/2018
• Supplement Date Received by Manufacturer: 10/30/2018
• Initial Report FDA Received Date: 06/11/2018
• Supplement Report FDA Received Date: 11/28/2018
• 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