MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL 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	Adhesion(s) (1695); Pain (1994); Loss of Range of Motion (2032); Neck Stiffness (2434)
Date of Event	07/28/2017
Type of Reportable Event	Serious Injury
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).
Event or Problem Description
It was reported by the affiliate that after an unknown procedure that was performed on (b)(6) 2017, the patient complained about pain, stiffness, and reduced motion range.The patient had a revision surgery, on (b)(6) 2019, which stabilized the joint and increased their range of motion.The dr.Removed the latarjet screws, adhesions, arthroscopically.
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.Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: this complaint is being documented since the patient experienced pain and stiffness and had to undergo a revision surgery to get the implants removed.There was no reported failure associated with the devices.However, there was patient harm.This complaint can be confirmed.The device was removed as a part of revision surgery but was unavailable for physical evaluation.No non-conformances were identified for this part-lot number combination per qlik query executed 02/15/2019.No further information regarding the technique or instruments used has been provided to determine a root cause for the reported issue.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).

• Brand Name: STERILE TOP HAT
• Common Device Name: SOFT-TISSUE, ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8367233
• Report Number: 1221934-2019-56482
• Device Sequence Number: 13932155
• Product Code: HWC
• UDI-Device Identifier: 10886705027088
• UDI-Public: 10886705027088
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2019

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: 08/31/2021
• Device Catalogue Number: 288231
• Device Lot Number: 3922297
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/01/2019
• Supplement Date Received by Manufacturer: 03/22/2019
• Initial Report FDA Received Date: 02/25/2019
• Supplement Report FDA Received Date: 04/15/2019
• Patient Sequence Number: 1
• Patient Age: 39 YR