MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACETABULAR REAMER HANDLE; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 2102-0410

Device Problems Failure To Adhere Or Bond (1031); Bent (1059)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/07/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Instrument came back from the hospital with a tag that says "broken do not use".Item is bent and will not hold reamers.

Manufacturer Narrative

An event regarding alleged damage involving an acetabular remear handle was reported.Conclusions: the device was shipped to the supplier, (b)(4), for evaluation.The supplier confirmed the event.The damaged device was discovered during inspection.There was no surgical procedure associated with the reported event.This event meets the definition of preventive maintenance.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Instrument came back from the hospital with a tag that says "broken do not use".Item is bent and will not hold reamers.

• Brand Name: ACETABULAR REAMER HANDLE
• 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: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6689504
• MDR Text Key: 79261931
• Report Number: 0002249697-2017-02106
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2102-0410
• Device Lot Number: V13297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/1999
• 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