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

Catalog Number 2107-2200

Device Problems Material Deformation (2976); Material Distortion (2977); Material Integrity Problem (2978); Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/04/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Flexible drill bit attachment from the acetabular screw pan stayed permanently bent at an angle after the small drill bit broke while trying drill for screws.A backup flexible drill bit attachment was used along with a backup drill bit.

Manufacturer Narrative

An event regarding damage (flexible drill shaft bent) involving a trident driver shaft was reported.The event was confirmed by visual inspection and material analysis review.Clinician review: not performed because no medical records or x-rays were made available for evaluation.Product history review: review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for this lot.Conclusions: the reported event of bent flexible drill shaft was confirmed by the return of the device.Visual inspection noted the bend in the flexible drill shaft and a material analysis engineer stated, ¿damage observed consistent with contact against a hard object and in-service use.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.¿.

Event Description

Flexible drill bit attachment from the acetabular screw pan stayed permanently bent at an angle after the small drill bit broke while trying drill for screws.A backup flexible drill bit attachment was used along with a backup drill bit.

• 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: 7231862
• MDR Text Key: 98758414
• Report Number: 0002249697-2018-00284
• 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: 04/03/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: 2107-2200
• Device Lot Number: B3MAW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2018
• Initial Date Manufacturer Received: 01/04/2018
• Initial Date FDA Received: 01/31/2018
• Supplement Dates Manufacturer Received: 03/07/2018
• Supplement Dates FDA Received: 04/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR