MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL PERMATAPE 2.5 WHITE/BLUE - 1PK; POLYETHYLENE SUTURE

Model Number	223170
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Local Reaction (2035)
Date of Event	08/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Udi: (b)(4).The lot number was unknown.Investigation summary: the complaint device is not being returned, it was implanted by the customer, therefore unavailable for a physical evaluation.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.Given that lot number was not provided, the manufacturing record evaluation (mre) review cannot be performed.If the lot number becomes available, the mre review will be performed.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.
Event or Problem Description
It was reported by the affiliate in (b)(6) that during an unknown procedure on (b)(6) 2021, the permatape 2.5 blue device was applied to the patient with metal allergy.It was reported that the surgeon wondered if raw materials used in the devices (chromium oxide, cobalt and aluminum) might have affected the patient.The status of the patient post-surgery was unknown.No additional information was provided.

• Brand Name: PERMATAPE 2.5 WHITE/BLUE - 1PK
• Common Device Name: POLYETHYLENE SUTURE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 12384918
• Report Number: 1221934-2021-02567
• Device Sequence Number: 14321623
• Product Code: GAT
• UDI-Device Identifier: 10886705027903
• UDI-Public: 10886705027903
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K162247
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/16/2021

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 Model Number: 223170
• Device Catalogue Number: 223170
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2021
• Initial Report FDA Received Date: 08/30/2021
• 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