MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CORACOID SCREW, 3.5MM; ORTHOPAEDIC IMPLANT INSERTER/EXTRACTOR

Catalog Number	288209
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4).The complaint devices were received and inspected.Visual observation confirms that minor nicks are seen at the inner side of the shank near the mounting end for both devices.The laser markings are faded slightly for both devices but they are readable.This complaint can be confirmed.Although a definite root cause cannot be determined, it is a possibility that this failure can be caused from repeated use and sterilization cycles which attributes to field wear.A dhr review has been conducted and the results indicate that this batch of product was processed without incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy synthes mitek complaints system revealed one dissimilar complaint for this lot of devices that were released to distribution.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.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
This is report 2 of 2 for the same event.It was reported by the sales rep that two of his 3.5mm coracoid screws were not twisting during a latarjet surgical procedure.The case was completed with another set.There were no patient consequences but three minute delay was reported.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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.If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4).Correction: device mfr date.

• Brand Name: CORACOID SCREW, 3.5MM
• Common Device Name: ORTHOPAEDIC IMPLANT INSERTER/EXTRACTOR
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8274648
• Report Number: 1221934-2018-53659
• Device Sequence Number: 1617010
• Product Code: LXH
• UDI-Device Identifier: 10886705026876
• UDI-Public: 10886705026876
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2017

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: 288209
• Device Lot Number: 16C01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2017
• Initial Date Received by Manufacturer: 04/26/2017
• Supplement Date Received by Manufacturer: 01/29/2019
• Initial Report FDA Received Date: 01/24/2019
• Supplement Report FDA Received Date: 01/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1