MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CRUCIATE+ RETROREAMER BULLET; LIGAMENT RECONSTRUCTION INSTRUMENT SET

Catalog Number	219004
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/21/2017
Type of Reportable Event	Malfunction
Additional 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 bullet, a review into the depuy synthes mitek complaints system revealed 1 similar and 1 dissimilar complaint for the lot of devices that were released to distribution.A review of the device history record indicated that this batch of product was processed without incident; therefore there is no evidence of manufacturing anomalies on the paperwork reviewed.For the twistr 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).Associated medwatch: 1221934-2018-54064.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 or Problem 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 8/29/2017 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 9-14-2017: the twistr 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: CRUCIATE+ RETROREAMER BULLET
• Common Device Name: LIGAMENT RECONSTRUCTION INSTRUMENT SET
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 7840669
• Report Number: 1221934-2018-54061
• Device Sequence Number: 1155649
• Product Code: LXH
• UDI-Device Identifier: 10886705025831
• UDI-Public: 10886705025831
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/21/2017

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
• Operator of Device: Health Professional
• Device Catalogue Number: 219004
• Device Lot Number: 1705001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2017
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/21/2017
• Initial Report FDA Received Date: 09/03/2018
• Patient Sequence Number: 1