MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL TRUESPAN 12 DEGREE PEEK; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number 228151

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/09/2018

Event Type  malfunction  

Manufacturer Narrative

If additional information should become available, a supplemental medwatch will be submitted accordingly.The complaint device is not being returned as it was discarded by the customer; therefore, unavailable for a physical evaluation.This complaint cannot be confirmed and an assignable root cause was not determined.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported by the sales rep via phone that during a meniscal repair procedure the sales rep's truespan meniscal repair peek 12 degree first suture and implant were exposed at the gun's tip.The sales rep stated that despite noticing the issue once unwrapping the device, they inserted the device into the patient's joint, but then removed before use.The case was completed with other four other like-devices with no patient harm or delays.The device was discarded by the customer.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

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.Evaluation statement: the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.However, photos of the actual device were provided.Based on the photos, it can be seen that that implant and the suture is exposed at the gun's tip.This confirms the reported issue of the device being received misassembled.The complaint was confirmed.A non-conformance search was performed for this product code 228151 lot l991738 combination and no non-conformances were identified.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.If any additional information is obtained, this complaint will be re-opened to capture that information.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.Udi: (b)(4).

• Brand Name: TRUESPAN 12 DEGREE PEEK
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8016136
• MDR Text Key: 125435592
• Report Number: 1221934-2018-55085
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 10886705026012
• UDI-Public: 10886705026012
• Combination Product (y/n): N
• PMA/PMN Number: K153667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 228151
• Device Lot Number: L991738
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1