MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC ME1000 BROACH-ADAPTER-ANTERIOR; IMPACTOR, ADAPTERS, BATTERY, BATTERY CHARGER

Catalog Number 1010-01-102

Device Problems Loose or Intermittent Connection (1371); Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Udi: lot/serial unknown.(b)(4).Device manufacture date: the device manufacture date is unavailable.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This is report 2 of 2 for the same event.It was reported that during a demonstration it was observed that two broach adapter devices were not tight and kept popping open when the impactor device was running.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was not reported.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

Manufacturer Narrative

Additional narrative: the serial number was documented as unknown in the initial medwatch report.The correct serial number (b)(4) has been documented in this medwatch report.Udi: (b)(4).It was documented in the initial medwatch report that the date of manufacture (dom) was unknown.The dom (november 2, 2017) has been updated to reflect the date the device was manufactured.The actual device was returned for evaluation.The device was evaluated and no failures were identified.Therefore, the reported condition was not confirmed and assignable root cause was not determined.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: ME1000 BROACH-ADAPTER-ANTERIOR
• Type of Device: IMPACTOR, ADAPTERS, BATTERY, BATTERY CHARGER
• 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: 8180735
• MDR Text Key: 131129506
• Report Number: 1045834-2018-52481
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 850915006044
• UDI-Public: (01)850915006044
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1010-01-102
• Device Lot Number: N/I
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2019
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2017
• 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