MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 4 ACCOLADE II BROACH; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number 1020-5204

Device Problems Fracture (1260); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/30/2023

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.

Event Description

A size 4 accolade 2 broach was placed in the femur and a calcar planer was used.During the procedure, a rasp handle become unable to attach to the broach.The rasp was pulled out using pliers.When the broach was later checked, the post (protruding part) was damaged, which leading failure to attach the rasp handle to it.

Manufacturer Narrative

An event regarding damage involving an accolade broach was reported.The event was confirmed.   method & results:  device evaluation and results: visual inspection noted that the device was returned in used condition.Damage consistent with in-service use was observed on the superior end of the broach.A functional inspection was performed with broach handle (cat 1020-1460, lot: p18n69).There was some difficulty assembling the broach to the handle without fully locking in.The event is confirmed.Damage consistent with in-service use clinician review: no medical records were received for review with a clinical consultant.Device 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 reported lot.Conclusion: visual inspection noted that the device was returned in used condition.Damage consistent with in-service use was observed on the superior end of the broach.A functional inspection was performed with broach handle (cat 1020-1460, lot: p18n69).There was some difficulty assembling the broach to the handle without fully locking in.The event is confirmed.Damage consistent with in-service use.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 Description

A size 4 accolade 2 broach was placed in the femur and a calcar planer was used.During the procedure, a rasp handle become unable to attach to the broach.The rasp was pulled out using pliers.When the broach was later checked, the post (protruding part) was damaged, which leading failure to attach the rasp handle to it.

• Brand Name: SIZE 4 ACCOLADE II BROACH
• Type of Device: 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16438038
• MDR Text Key: 310241681
• Report Number: 0002249697-2023-00188
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07613327252620
• UDI-Public: 07613327252620
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K153345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/11/2023

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
• Device Operator: Health Professional
• Device Model Number: 1020-5204
• Device Catalogue Number: 1020-5204
• Device Lot Number: 143250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2023
• Initial Date FDA Received: 02/24/2023
• Supplement Dates Manufacturer Received: 03/17/2023
• Supplement Dates FDA Received: 04/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other