MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DYNACORD BLUE W/O NDL 12PK; POLYETHYLENE SUTURE

Catalog Number	222067
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).The lot number was unknown.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported by the affiliate in (b)(6) that during a band revision surgery, it was observed that a dynacord¿ suture (blue), no needles, multi (12) pack broke when it was put on.No surgical delay or patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: b5: subsequent follow-up with the customer, additional information was received.It was reported that the procedure was completed without patient harm.D4: the lot number was reported as unknown on the initial report and has been updated as 4l01776.Therefore, udi: (b)(4).
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: correction: d2: the common device name has been updated to reflect the correct information.H6: method codes: upon further investigation, it was determined that the method codes reported on the initial report were not a correct representation of the investigation.Therefore, this field and the investigation summary have been updated accordingly to reflect the correct information.Investigation summary :according to the information provided, it was reported that a dynacord¿ suture (blue), no needles, multi (12) pack broke when it was put on.The complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.Since the complaint device was discarded, we cannot determine a root cause for the reported failure.If additional information is received in the future, we will reopen the complaint and perform the investigation as appropriate.A manufacturing record evaluation was performed for the finished device lot number:4l01776, and no non-conformances were identified.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.

• Brand Name: DYNACORD BLUE W/O NDL 12PK
• Common Device Name: POLYETHYLENE SUTURE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• MDR Report Key: 10270745
• Report Number: 1221934-2020-01810
• Device Sequence Number: 811672
• Product Code: GAT
• UDI-Device Identifier: 10886705030019
• UDI-Public: 10886705030019
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K181182
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/01/2020

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 Catalogue Number: 222067
• Device Lot Number: 4L01776
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/01/2020
• Supplement Date Received by Manufacturer: 07/27/2020; 09/02/2020
• Initial Report FDA Received Date: 07/14/2020
• Supplement Report FDA Received Date: 07/28/2020; 09/02/2020
• Patient Sequence Number: 1