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

Model Number 2107-2200

Device Problem Fracture (1260)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/03/2020

Event Type  malfunction  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.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.

Event Description

During total hip replacement surgery, the flex.Drill guide was broken while drilling for acetabular cup screws.20 min delay, right side."during the mounting process of total hip prothesis while screwing acetabular cup, flex drill guide is broken".

Manufacturer Narrative

Reported event: an event regarding crack/fracture involving a trident driver shaft was reported.The event was confirmed by analysis of the returned device.Method & results: device evaluation and results: visual inspection: visual inspection was performed as part of the material evaluation and indicated the following comments: the shaft was examined with the aid of a stereo-microscope at magnifications up to 50x.The distal fracture surface was examined using a scanning electron microscope (sem).Dimensional inspection: not performed as the reported device was returned damaged and in its current condition would not be an accurate reflection of its original manufactured condition.Functional inspection: not performed as the reported device was returned damaged and in its current condition would not be an accurate reflection of its original manufactured condition.Material analysis: material evaluation was completed and indicated the following comments: the shaft was examined with the aid of a stereo-microscope at magnifications up to 50x.The distal fracture surface was examined using a scanning electron microscope (sem).The fracture surface morphology was consistent with torsional overload.Energy dispersive spectrscopy showed that the base material of the flex shaft was consistent with 17-7 stainless steel.Based on the given information no materials discrepancies were observed on the surfaces examined.Clinician review: no medical records were received for review with a clinical consultant.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there has been no other similar event for the reported lot.Conclusion: the investigation concluded, as a result of analysis of the device "the fracture surface morphology was consistent with torsional overload.Energy dispersive spectroscopy showed that the base material of the flex shaft was consistent with 17-7 stainless steel.Based on the given information no materials discrepancies were observed on the surfaces examined.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

During total hip replacement surgery, the flex.Drill guide was broken while drilling for acetabular cup screws.20 min delay, right side "during the mounting process of total hip prothesis while screwing acetabular cup, flex drill guide is broken".

• 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: 10307928
• MDR Text Key: 199911744
• Report Number: 0002249697-2020-01525
• 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: company representative,other
• Type of Report: Initial,Followup
• Report Date: 10/20/2020

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 Expiration Date: 10/31/2023
• Device Model Number: 2107-2200
• Device Catalogue Number: 2107-2200
• Device Lot Number: BDCAP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2020
• Initial Date Manufacturer Received: 07/04/2020
• Initial Date FDA Received: 07/22/2020
• Supplement Dates Manufacturer Received: 09/23/2020
• Supplement Dates FDA Received: 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Weight: 75