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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2021
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.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.
Event or Problem Description
It was reported by the staff nurse that while using the flexible drill to drill for second screw hole, suddenly the flexible drill is broken into two pieces.So coincidentally another surgeon is using our thr set for his case as well and he done the case earlier than this surgeon.So (b)(4) manage to wash and autoclave back the flexible drill from previous case for this case but the surgeon have to wait another one hour just to wait for the flexible drill done autoclave.Surgical delay 60 minutes.Update 4 may 2021 ( additional information) : sales updated that - the surgeon feedback that the patient is not suffered from any adverse consequences.
Event or Problem Description
It was reported by the staff nurse that while using the flexible drill to drill for second screw hole, suddenly the flexible drill is broken into two pieces.So coincidentally another surgeon is using our thr set for his case as well and he done the case earlier than this surgeon.So tssu manage to wash and autoclave back the flexible drill from previous case for this case but the surgeon have to wait another one hour just to wait for the flexible drill done autoclave.Surgical delay 60 minutes.Update 4 may 2021 ( additional information) : sales updated that - the surgeon feedback that the patient is not suffered from any adverse consequences.
Additional Manufacturer Narrative
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 it is fractured into two pieces.The fracture occurred in the coiled portion of the device.Material analysis: a material analysis was performed and concluded the following: "the instrument failed due to cyclic stresses causing fatigue failure of a critical number of wire strands leading to overload failure of the remaining ones.No material nonconformances, nor manufacturing defects were found on any surface investigated here." see attached report.-clinician review: no medical records were received for review with a clinical consultant.-product history review: review of the device history records indicate 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 lot referenced.Conclusions: it was reported that the trident flexible drill shaft fractured during surgery.Visual inspection of the returned device indicated that it is fractured into two pieces.The fracture occurred in the coiled portion of the device.A material analysis was performed and concluded the following: "the instrument failed due to cyclic stresses causing fatigue failure of a critical number of wire strands leading to overload failure of the remaining ones.No material non-conformances, nor manufacturing defects were found on any surface investigated here." see attached report.No further investigation for this event is possible 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12317953
• Report Number: 0002249697-2021-01382
• Device Sequence Number: 2826440
• Product Code: LPH
• UDI-Device Identifier: 07613327212327
• UDI-Public: 07613327212327
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K161569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2022

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: B6TAW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/22/2021
• Supplement Date Received by Manufacturer: 06/14/2022
• Initial Report FDA Received Date: 08/13/2021
• Supplement Report FDA Received Date: 06/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2012
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR
• Patient Sex: Female