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

Model Number	2107-2200
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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".
Additional 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 or Problem 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
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10307928
• Report Number: 0002249697-2020-01525
• Device Sequence Number: 3371277
• Product Code: LPH
• UDI-Device Identifier: 07613327212327
• UDI-Public: 07613327212327
• Combination Product (Y/N): N
• PMA/510(K) Number: K161569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 07/04/2020
• Supplement Date Received by Manufacturer: 09/23/2020
• Initial Report FDA Received Date: 07/22/2020
• Supplement Report FDA Received Date: 10/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 54 YR
• Patient Weight: 75