MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL #4-0 OC VIOLET18 W/C-1NDL 12PK; POLYDIOXANONE SUTURE

Catalog Number	223127
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).
Event or Problem Description
It was reported by the customer via phone that during an unknown procedure the customer's orthocord size #4 violet broke.The customer was unable to provide the quantity of sutures that broke, as the used devices were discarded.The customer stated that the products came from the same lot number, and requested that the products on the shelf be returned.The customer was not present and unable to provide any information.The unused devices are being returned for evaluation.
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.The complaint device was discarded by the customer, therefore, is not available for a physical evaluation.The complaint cannot be confirmed.The customer returned unopened sutures from the same lot as the complaint device.Straight tensile testing was performed on 3 samples of the sutures to check their performance.After reviewing the test results with a mitek npd engineer, all the sutures were found to have met specifications.Therefore, the root cause for the reported failure could not be determined.A review into the depuy synthes mitek complaints system revealed no complaints of any kind for this lot released for distribution.A review of the device history record indicated that this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.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: #4-0 OC VIOLET18 W/C-1NDL 12PK
• Common Device Name: POLYDIOXANONE SUTURE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle CH-24 00; SZ CH-2400
• MDR Report Key: 7897561
• Report Number: 1221934-2018-54705
• Device Sequence Number: 1433809
• Product Code: NEW
• UDI-Device Identifier: 10886705022946
• UDI-Public: 10886705022946
• Combination Product (Y/N): N
• PMA/510(K) Number: K123668
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2018

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: 08/31/2020
• Device Catalogue Number: 223127
• Device Lot Number: AJ5984
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/21/2018
• Supplement Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 09/21/2018
• Supplement Report FDA Received Date: 10/18/2018
• Patient Sequence Number: 1