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	Foreign Body In Patient (2687); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2020
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.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
The customer returned an image of a detachable flex shaft showing that it had broken into two pieces.The customer further reported that small fragments of the instrument were noticed on the post-operative x-ray.A new instrument was used to complete the case.No treatment planned to address fragments left in the patient as there are no ¿issues¿ at present with patient.Delay of 30 seconds to open a new instrument.Left side.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a trident driver shaft was reported.The event was confirmed by inspection of received image of device.Method & results: product evaluation and results: the device was not returned.Visual inspection of the received image of the device noted that the device was fractured in two parts.Dimensional, functional and material analysis could not be performed as the device was not returned.Clinician review: not performed as no medical records were returned for review.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there were no other events for the lot provided.Conclusions: it was reported that the shaft has broken into two pieces.There was surgical delay of approximately 30 seconds.Visual inspection of the received image of the device noted that the device was fractured in two parts.The exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.Device not returned.
Event or Problem Description
The customer returned an image of a detachable flex shaft showing that it had broken into two pieces.The customer further reported that small fragments of the instrument were noticed on the post-operative x-ray.A new instrument was used to complete the case.No treatment planned to address fragments left in the patient as there are no ¿issues¿ at present with patient.Delay of 30 seconds to open a new instrument.Left side.
Event or Problem Description
The customer returned an image of a detachable flex shaft showing that it had broken into two pieces.The customer further reported that small fragments of the instrument were noticed on the post-operative x-ray.A new instrument was used to complete the case.No treatment planned to address fragments left in the patient as there are no ¿issues¿ at present with patient.Delay of 30 seconds to open a new instrument.Left side.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a trident driver shaft was reported.The event was confirmed.Method & results: product evaluation and results: visual inspection: visual inspection of the returned device indicated that the device is fractured.The fracture surface morphology was consistent with torsional overload from applying pressure to the shaft while rotating and bending.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.Product history review: review of the device history records indicate the devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusions: it was reported that the shaft had broken and fragments fell into and remain in the patient.Visual inspection of the returned device indicated that the device is fractured.The fracture surface morphology was consistent with torsional overload from applying pressure to the shaft in a rotating and bending motion.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.

• 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
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 10562172
• Report Number: 0002249697-2020-01950
• Device Sequence Number: 14147936
• Product Code: LPH
• UDI-Device Identifier: 07613327212327
• UDI-Public: 07613327212327
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K161569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/27/2022

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 Model Number: 2107-2200
• Device Catalogue Number: 2107-2200
• Device Lot Number: BDHAG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/26/2020
• Supplement Date Received by Manufacturer: 12/04/2020; 06/07/2022
• Initial Report FDA Received Date: 09/21/2020
• Supplement Report FDA Received Date: 12/21/2020; 06/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/03/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown