MAUDE Adverse Event Report: GREATBATCH MEDICAL SA NITINOL REAMER, MODULAR 16 MM; REAMER HEAD

Model Number MAL31900160NT

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/07/2015

Event Type  Injury  

Manufacturer Narrative

The device was returned on 02 november 2015, but in investigation has not yet been completed.Once (b)(4) completes the investigation, a supplemental medwatch 3500a form will be submitted.The information was received by the distributer (b)(4).The event occured in (b)(6).

Event Description

It was reported that the nitinol reamer broke and two (2) pieces fell into the femoral medullar canal.One (1) piece was removed but an x-ray shows that one (1) other piece remained in the patient.The surgery was delayed 20 minutes to look for the broken pieces.There have been no complications observed from the reamer being left in the patient.

Manufacturer Narrative

The device was evaluated and the reported event was confirmed.The device was found to be broken and only one of the broken fragments were returned.A manufacturing review was completed and no discrepancies were found.The malfunction was caused by torsional overload and wear.No further investigation is required.(b)(4).

• Brand Name: NITINOL REAMER, MODULAR 16 MM
• Type of Device: REAMER HEAD
• Manufacturer (Section D): GREATBATCH MEDICAL SA; l'echelette 7; ch-2534; orvin, ; SZ
• 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: 5221252
• MDR Text Key: 31072504
• Report Number: 9614497-2015-00230
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAL31900160NT
• Device Catalogue Number: T3306
• Device Lot Number: 6402300001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/14/2015
• Initial Date FDA Received: 11/12/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2011
• 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