MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL TWISTR ACL DISPOSABLES KIT; LIGAMENT RECONSTRUCTION INSTRUMENT SET

Catalog Number	232301
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the complaint device was not returned, therefore a physical evaluation cannot be performed.The complaint event was reported to have occurred during use on a cadaver.A photo was supplied at the time the complaint was created, this was used to evaluate the complaint device.The photo revealed the distal tip of the 14 inch drill pin was extending out of the bullet, appeared to be bent at the tip, and was broken off completely where it comes out of the other end of the bullet.The drill pin appears to be stuck inside the bullet, as reported in the event description.This complaint is confirmed.The photo was reviewed by an npd engineer as part of the evaluation.The npd engineer concluded that the drill pin likely got galled up in the bullet, and in trying to get them decoupled, the weld between the bullet and handle failed.If the drill pin was not straight, it could have started to gall during the drilling, which eventually caused it to seize together.It is likely that the drill pin broke into two pieces during the attempt to remove the stuck pin from the bullet, at the same time the handle broke off the bullet.A manufacturing record evaluation cannot be conducted as no lot numbers were provided.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.Udi: (b)(4).The lot number is unknown.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported by the affiliate via email that the failure of the cruciate+ beath pin bullet was identified during its correct use in a cadaverous course, the beath pin 14'', which was a part of the disposable kit got trapped and locked inside the bullet.When trying to release it, the bullet was broken and was remaining in 2 parts images attached.But still the drill did not come out.The received photo was reviewed by manufacturer and it shows a restore acl instruments 14" drill pt.Pin w/eyelet stuck inside the bullet complaint device.It is clear in the photo that the drill pin is about half the length it is supposed to be and also appears bent at the tip.The drill pin is part of the finished goods acl disposable kit.

• Brand Name: TWISTR ACL DISPOSABLES KIT
• 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: 8958076
• Report Number: 1221934-2019-58184
• Device Sequence Number: 13518541
• Product Code: KDD
• UDI-Device Identifier: 10886705026173
• UDI-Public: 10886705026173
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/03/2019

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: 232301
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/03/2019
• Initial Report FDA Received Date: 09/03/2019
• Patient Sequence Number: 1