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

Model Number	223169
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	11/25/2019
Type of Reportable Event	Malfunction
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 during an arthroscopic rotator cuff repair at the time when surgeon tried to thread the permatape 2.5 blue - 1pk into the implant, it broke.No patient consequence, however there was a surgical delay of less than 30 minutes.No additional information was provided.Additional information later reported by the affiliate reported the device will not be returning for evaluation and further information regarding the event is not available.
Event or Problem Description
Additional information provided by the affiliate reported the device will not be returning for evaluation.The affiliate also stated additional details pertaining to the case or patient are unavailable.
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.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.Additional information: - event description.Udi: (b)(4).
Additional Manufacturer Narrative
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 the information is unknown, not available or does not apply, the section/field of the form is left blank.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.H10 additional narrative: investigation summary = > the complaint device is not being returned, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device lot number 5l44889, and no non-conformances were identified.Since the complaint device was not returned, we cannot determine a root cause for the reported failure.If the device is received in the future, we will reopen the complaint and perform the investigation as appropriate.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.Device history lot = > a manufacturing record evaluation was performed for the finished device lot/serial number (b)(6), and no non-conformances were identified.

• Brand Name: PERMATAPE 2.5 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: 9439651
• Report Number: 1221934-2019-59907
• Device Sequence Number: 3337651
• Product Code: GAT
• UDI-Device Identifier: 10886705027897
• UDI-Public: 10886705027897
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K162247
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/25/2019

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 Expiration Date: 06/30/2022
• Device Model Number: 223169
• Device Catalogue Number: 223169
• Device Lot Number: 5L44889
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/25/2019
• Supplement Date Received by Manufacturer: 12/03/2019; 01/27/2020
• Initial Report FDA Received Date: 12/09/2019
• Supplement Report FDA Received Date: 12/23/2019; 01/28/2020
• Patient Sequence Number: 1