MAUDE Adverse Event Report: GREATBACH MEDICAL SAA ACETABULAR REAMER HANDLE

Model Number 2102-0410

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 06/12/2014

Event Type  malfunction  

Event Description

Per email received july 01, 2014 customer reports; during an unknown procedure on a female patient, the shaft tip that connects to the drill broke off.No patient injury or adverse events were reported as a result of the incident.Procedure was completed without surgical delay.

Manufacturer Narrative

It has been communicated by the customer that the device will be returned to greatbatch medical for evaluation.Once greatbatch medical receives the device, an investigation will be performed and a supplemental medwatch 3500a form will be submitted.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.The tip of the power adapter has failed.Failure shows evidence of impact and combined with the small dimples on the end of the driver indicate misuse.Manual surgical instruments have a limited life span which is generally determined by wear or damage due to repeated intended use.No further investigation required.

Manufacturer Narrative

Greatbatch medical is not the legal manufacturer of the device involved in this incident.

• Brand Name: ACETABULAR REAMER HANDLE
• Type of Device: REAMER HANDLE
• Manufacturer (Section D): GREATBACH MEDICAL SAA; l' echelette 7; orvin CH-25 34; SZ CH-2534
• Manufacturer (Section G): GREATBATCH MEDICAL SA; l'echelette 7; ch-2534; orvin, ; SZ
• Manufacturer Contact: noe rivera ; 4545 kroemer road; fort wayne, IN 46818 ; 2607557490
• MDR Report Key: 4004733
• MDR Text Key: 4952258
• Report Number: 9614497-2014-00186
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor,distributor,health prof
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup,Followup
• Report Date: 05/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2102-0410
• Device Catalogue Number: T2452
• Device Lot Number: 56468175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/01/2014
• Initial Date FDA Received: 07/25/2014
• Supplement Dates Manufacturer Received: 05/14/2016; 05/14/2016
• Supplement Dates FDA Received: 10/14/2014; 05/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2005
• 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