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

Catalog Number 2107-2200

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/16/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Primary procedure, right hip.During procedure, the flexible drill shaft bent in half when drilling for acetabular screws.Rep reported there was no surgical delay and no harm to the patient.

Event Description

Primary procedure, right hip.During procedure, the flexible drill shaft bent in half when drilling for acetabular screws.Rep reported there was no surgical delay and no harm to the patient.

Manufacturer Narrative

An event regarding damage involving an trident driver shaft was reported.The event was not confirmed.Conclusions: the event could not be confirmed nor the root cause determined because the products were not returned for evaluation and insufficient medical information was provided.If the products and/or additional information are received, this investigation will be reopened and re-evaluated.

• 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
• MDR Report Key: 7266824
• MDR Text Key: 100064128
• Report Number: 0002249697-2018-00398
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K161569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2018
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR