MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNIVERSAL DRIVER SHAFT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	2107-1015
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported that during a right total hip replacement, the universal joint screwdriver broke.Another screwdriver was procured from the field back.Rep reports that there was no surgical delay, no adverse effects to the patient, and that the procedure was completed successfully.
Additional Manufacturer Narrative
An event regarding crack/fracture involving a trident driver shaft was reported.The event was confirmed.A visual inspection of returned device noted that the devices was returned in used condition.The hexalobular tip of the screwdriver shaft was found to be fractured and deformed.Material analysis is not required for the universal driver shaft as it falls in the scope of capa.A review of medical records was not performed because no medical records or x-rays were made available for evaluation.Review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.There has been 03 other event for the lot referenced.The reported event was confirmed as per visual inspection of the returned device which shows that the hexalobular tip of the screwdriver shaft was fractured and deformed.The deformation to the driver indicates the tip was deformed while the device was being used to tighten a screw.Material analysis is not required for the universal driver shaft as it falls in the scope of capa.The capa investigation found that the failure mode is observed when the driver is over torqued, the driver tip wears excessively due to repeated use of the driver, or when the driver tip is angulated extremely within the screw head during use.
Event or Problem Description
It was reported that during a right total hip replacement, the universal joint screwdriver broke.Another screwdriver was procured from the field back.Rep reports that there was no surgical delay, no adverse effects to the patient, and that the procedure was completed successfully.

• Brand Name: UNIVERSAL DRIVER SHAFT
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 6810157
• Report Number: 0002249697-2017-02569
• Device Sequence Number: 19266372
• Product Code: LPH
• UDI-Device Identifier: 07613327212280
• UDI-Public: 07613327212280
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K153345
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2017

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: 2107-1015
• Device Lot Number: F11T11332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2017
• Initial Date Received by Manufacturer: 07/26/2017
• Supplement Date Received by Manufacturer: 09/18/2017
• Initial Report FDA Received Date: 08/22/2017
• Supplement Report FDA Received Date: 10/16/2017
• 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
• Patient Age: 58 YR