MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL STERILE LATARJET SCREW, 28MM; SOFT-TISSUE, ANCHOR, NON-BIOABSORBABLE

Catalog Number	288222
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Codes	Not Applicable (3189); No Code Available (3191)
Date of Event	04/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4).Investigation summary: the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.No nonconformances were identified for this part number, lot number combination per qlik query executed on 4/24/2019.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.If any additional information is obtained, this complaint will be re-opened to capture that information.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).
Event or Problem Description
This is report 3 of 4 for the same event.It was reported by the sales rep via phone that during a latarjet procedure, the two 30mm sterile latarjet screws were inserted and did not flush to the glenoid and cortical.The sales rep stated that a 28mm sterile latarjet screw was opened, but also did not flush to the glenoid and cortical.A 34mm sterile latarjet screw was opened and also did not flush to the glenoid and cortical.These screws did not provide the compression necessary to complete the case and each was removed from the patient with no debris left behind.The case was completed by shaving the cortical further and using a 32mm screw and a 34mm screw, which was different from the complaint screw.There was a surgical delay, but it was not specified how long.There was no patient harm reported.The sales rep was not present and could not provide any additional information.The devices were discarded by the customer.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.

• Brand Name: STERILE LATARJET SCREW, 28MM
• Common Device Name: SOFT-TISSUE, ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8582420
• Report Number: 1221934-2019-57020
• Device Sequence Number: 1857582
• Product Code: HWC
• UDI-Device Identifier: 10886705026999
• UDI-Public: 10886705026999
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K110763
• 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
• Report Date (Section B): 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 288222
• Device Lot Number: L641881
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2019
• Initial Report FDA Received Date: 05/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention