MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER RASP SIZE 2 37.5/44MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 0580-3744-2

Device Problems Material Distortion (2977); Naturally Worn (2988)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/11/2018

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

The size number is hard to see.After many times of use, the number is erased.

Manufacturer Narrative

An event regarding product marking involving an exeter rasp was reported.Conclusion: the device was discovered during inspection.The device was returned in used condition.The part of the device where the size marking is located appears to have abrasions and the size marking is wearing off.A material analysis engineer noted, ¿damage observed on broach consistent with in-service use and contact against a hard object.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.¿ 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.

Event Description

The size number is hard to see.After many times of use, the number is erased.

• Brand Name: EXETER RASP SIZE 2 37.5/44MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7498636
• MDR Text Key: 107741870
• Report Number: 0002249697-2018-01372
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K153345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 07/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0580-3744-2
• Device Lot Number: TDCM81M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2018
• Date Manufacturer Received: 06/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other