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

Catalog Number 1010-01-101

Device Problems Detachment of Device or Device Component (2907); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/13/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device manufacture date: the device manufacture date is unavailable.The actual device has been returned and is currently pending evaluation.Once the evaluation of the device has been completed, a supplemental medwatch report will be sent accordingly.

Event Description

It was reported that during service and evaluation it was observed that the broach adaptor device did not hold the actis broach securely.It was further observed that the locking latch was loose and the actis broach did not have a secure connection and was moving in multiple directions.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative: it was documented in the initial medwatch report that the date of manufacture (dom) was unknown.The dom (b)(6) 2017) has been updated to reflect the date the device was manufactured.Device evaluation: the actual device was returned without an alleged deficiency.During routine service and repair of the device, it was observed that the broach adapter did not hold the actis broach securely, when locked the actis broach was moving in multiple directions and felt loose.The broach did move when latched into the adapter, but no defect was found.It was determined that the movement was normal and was due to wear of the adapter over time and does not affect the functionality of the adapter and broach.A review of the device history was performed and no non-conformance's were detected related to the reported condition.If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi ¿ (b)(4).

• Brand Name: ME1000 BROACH-ADAPTER-STRAIGHT
• Type of Device: IMPACTOR, ADAPTERS, BATTERY, BATTERY CHARGER
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 8373816
• MDR Text Key: 137270791
• Report Number: 1045834-2019-52976
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 00850915006037
• UDI-Public: 850915006037
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1010-01-101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2019
• Date Manufacturer Received: 04/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1