MAUDE Adverse Event Report: GREATBATCH MEDICAL SA ACETABULAR REAMER 50MM

Model Number 2102-0450

Device Problems Dull, Blunt (2407); Naturally Worn (2988)

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

Event Date 04/05/2013

Event Type  malfunction  

Event Description

Per email received (b)(4), 2013 customer reports; during a tha on male patient (b)(4), the surgeon felt that the reamers were dull.No patient injury or adverse events reported.Surgery was completed without surgical delay.Incident is reportable in (b)(6) as event occurred in (b)(6).

Manufacturer Narrative

Complaint sample was evaluated and rhe reported event was confirmed.Dhr was not reviewed.Manual surgical instruments have a limited life-span which is generally determined by wear or damage due to repeated intended use.Trend analysis was performed from jan 2008 to dec 2012 and 311 similar events have been reported.No further investigation required.

Manufacturer Narrative

(b)(4) medical is not the legal manufacturer of the device involved in this incident.

• Brand Name: ACETABULAR REAMER 50MM
• Type of Device: REAMER
• Manufacturer (Section D): GREATBATCH MEDICAL SA; l' echelette 7; orvin 2534 ; SZ 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: 3853626
• MDR Text Key: 4410194
• Report Number: 9614497-2014-00051
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,foreign,health profe
• Reporter Occupation: Not Applicable
• Type of Report: Initial,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: 2102-0450
• Device Lot Number: V2009034
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/10/2013
• Initial Date Manufacturer Received: 04/22/2013
• Initial Date FDA Received: 04/03/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Other
• Patient Age: 60 YR