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	01/31/2020
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.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.
Event or Problem Description
After the installation of the trident cup, drilling was performed using a drill guide to fix the screw.The drill tip was broken because the bone was hard and drilled many times.The parts did not fall into the patient.The operation was continued and terminated using another instrument.Update: "it seems that it is less than one minute because they just changed the drill.".
Additional Manufacturer Narrative
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 received in two parts.Examination of the device by a material analysis engineer noted that 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 spectrscopy 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: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.-complaint history review: there has been 1 other event for the lot referenced.Conclusions: it was reported that after the installation of the trident cup, drilling was performed using a drill guide to fix the screw.The drill tip was broken because the bone was hard and drilled many times.Examination of the device by a material analysis engineer noted that 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 spectrscopy 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.
Event or Problem Description
After the installation of the trident cup, drilling was performed using a drill guide to fix the screw.The drill tip was broken because the bone was hard and drilled many times.The parts did not fall into the patient.The operation was continued and terminated using another instrument.Update: "it seems that it is less than one minute because they just changed the drill.".

• 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: 9772197
• Report Number: 0002249697-2020-00419
• Device Sequence Number: 2890569
• 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): 05/05/2020

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: 02/28/2017
• Device Model Number: 2107-2200
• Device Catalogue Number: 2107-2200
• Device Lot Number: B6TAX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Initial Date Received by Manufacturer: 01/31/2020
• Supplement Date Received by Manufacturer: 04/07/2020
• Initial Report FDA Received Date: 02/28/2020
• Supplement Report FDA Received Date: 05/05/2020
• 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