MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL STERILE TOP HAT; SOFT-TISSUE, ANCHOR, NON-BIOABSORBABLE

Catalog Number	288231
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Discomfort (2330); No Code Available (3191)
Date of Event	03/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.(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 non-conformances were identified for this part (288231) - lot number (3922587) combination as per qlik query executed 04/15/2019.This complaint is being documented since the patient experiences discomfort and had to undergo a surgical intervention.There was no alleged device malfunction.No further information regarding the technique or instruments used has been provided to determine a root cause for this event.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.Udi: (b)(4).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
Device report from (b)(6) reports an event as follows: it was reported by the affiliate via email that after the removal of a latarjet screw, it was noticed that the inferior aspect of coracoid bone graft had been resorbed, exposing the screw.The patient has complained of some irritation, instability, and discomfort on external rotation.The screw was removed and the surgeon tightened anterior capsule.The affiliate reported that there was no adverse event to patient and no time delay to the case.The product was discarded and will not be returning for evaluation.This is report 2 of 2 for complaint (b)(4).

• Brand Name: STERILE TOP HAT
• 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: 8523003
• Report Number: 1221934-2019-56869
• Device Sequence Number: 1899971
• Product Code: HWC
• UDI-Device Identifier: 10886705027088
• UDI-Public: 10886705027088
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K110763
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/19/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 288231
• Device Lot Number: 3922587
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/19/2019
• Initial Report FDA Received Date: 04/17/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention