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 Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
The flexible shaft drill was broken during the operation.The product was exchanged with the same new one.The procedure continued and completed without problem.The reporting surgeon¿s opinion: due to the patient¿s bone quality or other factors the drill had to be used for long time.
Event or Problem Description
The flexible shaft drill was broken during the operation.The product was exchanged with the same new one.The procedure continued and completed without problem.The reporting surgeon¿s opinion: due to the patient¿s bone quality or other factors the drill had to be used for long time.
Additional Manufacturer Narrative
An event regarding crack/fracture involving a trident driver shaft was reported.The event was confirmed by evaluation of the returned device by a material analysis engineer.Method & results: device evaluation and results: the visual inspection confirmed that the driver shaft was returned fractured.A material evaluation was completed and indicated the following comments: the detachable flex shaft was returned fractured, 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 "spectroscopy" showed that the base material of the flex shaft was consistent with 17-7 stainless steel.Based on the given information no materials or manufacturing discrepancies were observed on the surfaces examined.Clinician review: no medical records were received for review with a clinical consultant -device history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar event for the lot referenced.Conclusion: it was reported that the driver shaft fractured during surgery.A material evaluation was completed and indicated the following comments: the detachable flex shaft was returned fractured, 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 "spectroscopy" showed that the base material of the flex shaft was consistent with 17-7 stainless steel.Based on the given information no 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.

• 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: 9603280
• Report Number: 0002249697-2020-00132
• Device Sequence Number: 547183
• 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: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2020

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: 08/31/2019
• Device Model Number: 2107-2200
• Device Catalogue Number: 2107-2200
• Device Lot Number: B9KCZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2020
• Initial Date Received by Manufacturer: 12/20/2019
• Supplement Date Received by Manufacturer: 04/10/2020
• Initial Report FDA Received Date: 01/17/2020
• Supplement Report FDA Received Date: 05/08/2020
• 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