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

Catalog Number 2107-2200

Device Problems Break (1069); Fracture (1260); Material Fragmentation (1261); Material Integrity Problem (2978)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 01/04/2016

Event Type  malfunction  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Additional information has been requested and if received, will be provided in the supplemental report.Not returned to manufacturer.

Event Description

It was reported that the shaft broke in-vivo when drilling into trident shell.It was reported that several small fragments of metal were scattered throughout the wound.

Manufacturer Narrative

An event regarding an alleged fracture involving a detachable flex shaft was reported.The event was confirmed.Method and results: device evaluation and results: the flexible shaft had separated near the midpoint of the device.At the point of separation, individual flexible shaft cables were uncoiled along one half and then twisted and frayed downward toward the drive fitting.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Device history review: a review of the device history records could not be performed as no lot information was provided.Complaint history review: a complaint history review confirmed one similar events for the reported lot.Conclusions: the flexible shaft had separated near the point of juncture with the drive fitting.At the point of separation, individual shaft cables were twisted and frayed, suggesting excessive force and/or fatigue.

Event Description

It was reported that the shaft broke in-vivo when drilling into trident shell.It was reported that several small fragments of metal were scattered throughout the wound.

• Brand Name: DETACHABLE FLEX 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: 5405900
• MDR Text Key: 37664620
• Report Number: 0002249697-2016-00275
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K151264
• 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: 01/07/2016

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: 2107-2200
• Device Lot Number: BSH16AP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/07/2016
• Initial Date FDA Received: 02/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/1999
• 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: 78 YR