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

Catalog Number 2107-2200

Device Problems Crack (1135); Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/26/2019

Event Type  malfunction  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device not returned.

Event Description

Flexible drill shaft (21072200) snapped while surgeon was drilling 3rd bone screw.Surgeon was unable to complete prep for bone screws as intended.No replacement device available.This led to a ten minute surgical delay.

Manufacturer Narrative

Reported event: an event regarding crack/fracture involving a trident driver shaft was reported.The event was confirmed by inspection of the returned device.Method & results: device evaluation and results: visual inspection of the returned device noted that the device was returned in used condition.The device is observed to be fractured at one of the end.Examination of the returned device with engineer indicated that the device is fractured due to an overload condition.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Dimensional and functional analysis was not performed as the device was returned in fractured condition.Clinician review: no medical records were received for review with a clinical consultant.Device history review: device history review indicated the devices were accepted into final stock from the reported lot were free from discrepancies.-complaint history review: there has been no other event for the lot referenced.Conclusions: it was reported that flexible drill shaft snapped while surgeon was drilling 3rd bone screw.There was a surgical delay of 10 minutes.Visual inspection of the returned device noted that the device was returned in used condition.The device is observed to be fractured at one of the end.Examination of the returned device with engineer indicated that the device is fractured due to an overload condition.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Flexible drill shaft (21072200) snapped while surgeon was drilling 3rd bone screw.Surgeon was unable to complete prep for bone screws as intended.No replacement device available.This led to a ten minute surgical delay.

• 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: 8540892
• MDR Text Key: 142794893
• Report Number: 0002249697-2019-01686
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07613327212327
• UDI-Public: 07613327212327
• 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: 06/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2019
• 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: B7AAS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• Date Manufacturer Received: 05/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other