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

Catalog Number	219003
Medical Device Problem Code	Break (1069)
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).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).The lot number is unknown.
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.
Additional Manufacturer Narrative
Product complaint # : (b)(4).Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.The complaint device is not being returned for evaluation, 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 will be used to evaluate the complaint device.The photo revealed the knob was detached from the bullet, and a drill bit appeared to be stuck inside the bullet.This complaint can be 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.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.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.

• Brand Name: CRUCIATE+ BEATH PIN 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: 8756231
• Report Number: 1221934-2019-57512
• Device Sequence Number: 13875714
• Product Code: LXH
• UDI-Device Identifier: 10886705025855
• UDI-Public: 10886705025855
• Combination Product (Y/N): N
• 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,Followup,Followup
• Report Date (Section B): 06/05/2019

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: 219003
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2019
• Initial Date Received by Manufacturer: 06/05/2019
• Supplement Date Received by Manufacturer: 08/27/2019; 09/03/2019
• Initial Report FDA Received Date: 07/02/2019
• Supplement Report FDA Received Date: 08/30/2019; 09/03/2019
• Patient Sequence Number: 1