MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL SPEEDTRAP GRN/WHITE 30MM 4PK; POLYETHYLENE SUTURE

Catalog Number	223750
Medical Device Problem Codes	Break (1069); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Udi: (b)(4).
Event or Problem Description
It was reported that while pulling the suture in line with graft, suture shredded and broke.It seemed like the suture was partially pinched in the plastic holder.We tried a couple off different devices and the same thing happened.There was no patient consequence.The procedure was completed with another speedtrap device from a different lot and it worked fine.
Event or Problem Description
Additional information received from the sales rep on 05/22/2018 stating: all three suture breaks occurred while tensioning the suture limbs.The breaks were where the suture exits the delivery device.The pa that was prepping the graft is very experienced with this device.The fourth device used to complete the procedure was from a different lot number.No devices are being returned.
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 medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary = > the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.  a device history record review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that for this batch of product a ncr/mrr/wo was generated, nevertheless this non-conformance is not relevant to the complaint condition.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.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: SPEEDTRAP GRN/WHITE 30MM 4PK
• Common Device Name: POLYETHYLENE SUTURE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 7616113
• Report Number: 1221934-2018-52062
• Device Sequence Number: 16499949
• Product Code: GAT
• UDI-Device Identifier: 20886705027177
• UDI-Public: 20886705027177
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K161638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2018

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: 05/31/2022
• Device Catalogue Number: 223750
• Device Lot Number: L436574
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/21/2018
• Supplement Date Received by Manufacturer: 05/22/2018
• Initial Report FDA Received Date: 06/19/2018
• Supplement Report FDA Received Date: 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1