MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL RETROREAMER (6-12MM); CANNULATED SURGICAL DRILL, SINGLE-USE

Catalog Number 232000

Device Problem Separation Failure (2547)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/21/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The two complaint devices were received and evaluated by an npd engineer.Visual observation revealed that the retroreamer was stuck/jammed inside the bullet.The bullet device was sectioned in half and it was found that there was galling between the retroreamer sleeve and the bullet which caused it to get stuck.The complaint could thus be confirmed.There are a couple of possibilities that might have led to this failure.It is possible that there was a side load on the bullet from the reamer causing the two to interfere.There is also a possibility that the drill was spinning in the same location within the bullet for a prolonged period causing the material to kick up and gall.Apart from these possibilities, however, we cannot discern a definite root cause for the reported failure at this point in time.For the twister retroreamer, no lot number was supplied which precludes conducting a dhr review or a lot specific search in the complaints handling system.At this point in time, no corrective action is required and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.(b)(4)-incomplete.Associated medwatch: 1221934-2018-54061.This report is being filed from the etq complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.

Event Description

The sales rep reported via phone that the customer's cruciate + retroreamer welded into the bullet during an acl procedure.The case was completed by removing the bullet and using another like device.There were no patient consequences or delays.The device is being returned.Additional information received on 8/29/17 via phone call.The retroreamer got stuck/jammed into the bullet, there were no issues with misalignment or the angle.The doctor decided to use another bullet and retroreamer.No patient consequences, the procedure was successfully completed using another device.Alternatives were readily available.Information received via phone from our sales rep on 9-14-17.The twister got stuck into the bullet during drilling into the joint space.The surgeon was trying to make a bone tunnel, but never made it since it got stuck.No damage was observed on the retroreamer or the bullet prior to use.The bullet was used around 5 times before this incident.This was the first failure that occurred with it.The blade had not been previously deployed.

• Brand Name: RETROREAMER (6-12MM)
• Type of Device: CANNULATED SURGICAL DRILL, SINGLE-USE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS SARL; rue du puits-godet 20; neuchâtel CH-20 00; SZ CH-2000
• Manufacturer Contact: jennifer lawrence ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7840666
• MDR Text Key: 119663283
• Report Number: 1221934-2018-54064
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10886705025626
• UDI-Public: 10886705025626
• 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: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 232000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1