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.
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 product inspection.Conclusions: the investigation concluded that the fracture was caused by an external force exceeding the maximum permissible torque.The suppliers inspection noted indications of wear on the torque scale above the 180 lb-in.Indication jn the clockwise direction and deflection of the tip of the pointer consistent with torque above 180 lb-in.The surgical protocol indicates the instrument be used to tighten a stem at 120-180 in/lb or an augment at 60-80 in/lb to the femoral component.If additional information becomes available to indicate further evaluation is warranted, 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: 7588855
• Report Number: 0002249697-2018-01771
• Device Sequence Number: 144187
• 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