MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC ME1000 REPL CAP FOR HEAD ADAPTER FEMORAL; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number 1013-00-901

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/09/2018

Event Type  malfunction  

Manufacturer Narrative

Device history record review: a device history review was performed and no non-conformances were detected related to the reported condition.Device evaluation: the device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Quality engineering evaluated the device and observed that the polymeric cap was dented.It was further determined that denting of the end cap was a normal result and the denting did not affect the function of the cap.It was determined that the damage was caused by normal wear.Therefore, the reported condition was confirmed.The assignable root cause was due to normal wear out from use.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that during service and repair pre-testing, it was discovered that the cap for head adapter femoral device failed visual assessment and the polymeric cap was dented.The event was not related to surgery.There was no patient involvement.There were no injuries or medical intervention associated with this event.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

Upon further review of the complaint, it was determined that the reported malfunction is unlikely to cause or contribute to serious injury or death if it were to recur.Therefore, this complaint is not reportable.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ME1000 REPL CAP FOR HEAD ADAPTER FEMORAL
• Type of Device: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): TECHTRONIC INDUSTRIES MEDICAL; 1428 pearman dairy rd; anderson SC 29625
• Manufacturer Contact: kara ditty-bovard ; 4500 riverside drive; palm beach gardens, FL 33410 ; 6103142063
• MDR Report Key: 8212020
• MDR Text Key: 131903594
• Report Number: 1045834-2019-52539
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 850915006143
• UDI-Public: (01)850915006143(11)170419
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1013-00-901
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2019
• Date Device Manufactured: 04/19/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1