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

Catalog Number 2107-1015

Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 11/02/2016

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

Per sales rep, patient had total hip surgery.The tip broke off when screwing into the cup.The tip was in the screw head.

Manufacturer Narrative

An event regarding crack/fracture involving a universal driver shaft was reported.The event was confirmed.Method & results: -device evaluation and results: the device was returned in used condition.The hexalobular tip of was broken off.The broken piece was not included with the returned driver shaft.-medical records received and evaluation: not performed as no medical records were provided.-device history review: review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been 6 other events for this lot.Conclusions: the investigation concluded this reported event falls in the scope a capa as evidenced by the condition of the returned device.This capa determined the failure mode is user related.This 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.The capa included a clinician assessment of the worst case condition of the tip breaking off the universal driver and being implanted.The assessment stated there is minimal health risk as the tip is imbedded between the screw and insert (i.E.Limited exposure).

Event Description

Per sales rep, patient had total hip surgery.The tip broke off when screwing into the cup.The tip was in the screw head.

• Brand Name: UNIVERSAL DRIVER SHAFT
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6136015
• MDR Text Key: 61146754
• Report Number: 0002249697-2016-03790
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/21/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: 2107-1015
• Device Lot Number: F4T8678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2016
• Initial Date FDA Received: 11/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 43 YR
• Patient Weight: 86