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

Catalog Number 228151

Device Problems Positioning Failure (1158); Migration (4003)

Patient Problems Not Applicable (3189); No Code Available (3191)

Event Date 09/09/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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 Description

It was reported by the sales rep via phone that during a meniscal repair procedure the second implant on their truespan peek 12 degree pulled out when the surgeon was tightening.They removed the first implant with no issue.When trying to use their second truesapn peek 12 degree, the device made a strange noise when pressing the trigger and the first implant would not deploy.The procedure was completed by using a competitor's device with no patient harm but there was a seven minute surgical delay to the case.The implants were discarded from the first gun but the gun itself and the second device will be returning for evaluation.

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 device was received for evaluation.Visual inspection of the exterior of the device showed no anomalies on it.The sleeve was removed from the shaft and the anchors are not there.There are no anomalies on the shaft of the device.We cannot confirm the reported failure of the implant pulling out.No nonconformances were identified for this part number, lot number combination.Review conducted per qlik query executed on 11/4/2019.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.Therefore, we cannot determine what caused the user to experience the reported event, we cannot discern a root cause for the reported failure mode.At this point in time, no corrective action is required, and no further action is warranted.However, should any new information be provided in future, this file will be re-opened, and a thorough investigation will be performed.Depuy 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 no nonconformances were identified for this part number, lot number combination.Review conducted per qlik query executed on 11/4/2019.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.

• 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: 9166203
• MDR Text Key: 161531443
• Report Number: 1221934-2019-58818
• 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
• Type of Report: Initial,Followup
• Report Date: 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 228151
• Device Lot Number: 1L49205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2019
• Date Manufacturer Received: 11/04/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention