MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH QUICK-CONNECT HANDLE (2/PK); PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	8000-0000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the product history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There has been one other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
This pi is for the intra-operative event on (b)(6) /2018.In performing a revision of the patient's right hip, the distal cone body was found to be cold welded to the distal stem.In using the stem separator and the handle which attaches to it, a part of the stem separator broke, and the tip of the handle snapped off.Surgeon had to instead perform an extensive troch osteotomy procedure, leading to a surgical delay of approximately 5 hours.
Event or Problem Description
This pi is for the intra-operative event on (b)(6) 2018.In performing a revision of the patient's right hip, the distal cone body was found to be cold welded to the distal stem.In using the stem separator and the handle which attaches to it, a part of the stem separator broke, and the tip of the handle snapped off.Surgeon had to instead perform an extensive troch osteotomy procedure, leading to a surgical delay of approximately 5 hours.
Additional Manufacturer Narrative
An intra-operative event regarding fracture of the device and failure to perform of a scorpio handle was reported.The event was confirmed through material analysis.A material analysis has been performed.The report concluded that the tip of the handle had fractured, with the fracture being consistent with an overload condition.The plunger shaft of the handle was damaged, consistent with contact against a hard object post-fracture.Eds showed the body handle was consistent with 17-4 ph stainless steel alloy.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.No medical records were received for review with a clinical consultant all devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the reported lot.It was reported that during a revision surgery for infection the distal cone body was found to be cold welded to the distal stem.In using the stem separator and the handle which attaches to it, a part of the stem separator broke, and the tip of the handle snapped off resulting in the surgeon having to perform an extensive troch osteotomy procedure, leading to a surgical delay of approximately 5 hours.The event was confirmed through material analysis of the returned instruments which concluded that the tip of the handle had fractured, with the fracture being consistent with an overload condition.The plunger shaft of the handle was damaged, consistent with contact against a hard object post-fracture.Eds showed the body handle was consistent with 17-4 ph stainless steel alloy.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.The exact cause of the event could not be determined because insufficient information was provided.Additional information, including operative reports and medical records are needed to fully investigate the event.If further information becomes available, this investigation will be re-opened.

• Brand Name: QUICK-CONNECT HANDLE (2/PK)
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7852231
• Report Number: 0002249697-2018-02787
• Device Sequence Number: 1337703
• Product Code: JWH
• UDI-Device Identifier: 07613327234206
• UDI-Public: 07613327234206
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K123486
• 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): 12/12/2018

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 Catalogue Number: 8000-0000
• Device Lot Number: MMZA23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2018
• Initial Date Received by Manufacturer: 08/09/2018
• Supplement Date Received by Manufacturer: 11/14/2018
• Initial Report FDA Received Date: 09/06/2018
• Supplement Report FDA Received Date: 12/12/2018
• 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: Hospitalization; Other
• Patient Age: 52 YR