MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL TRUESPAN 24 DEGREE PEEK; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number 228152

Device Problems Loss of or Failure to Bond (1068); Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (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).Associated medwatch: 1221934-2018-53962.

Event Description

Implants not attached to the suture.No patient consequences.Is the information being submitted for this complaint all the details that are known/available regarding this event? : yes.

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.¿ udi: (b)(4).Associated medwatch: 1221934-2018-53962.

Event Description

Implants not attached to the suture.No patient consequences.Is the information being submitted for this complaint all the details that are known/available regarding this event? : yes.

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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 was received and inspected.The complaint cannot be confirmed, as it was observed that the implants were not present inside the device or in the package received.It was observed that the distal tip of the plastic sleeve was deformed indicating that the device had been previously used.Given the information provided, we cannot discern a definitive root cause for the reported failure.A non-conformance search was conducted to investigate any defects during production identified that may contribute to the complaint condition.No non-conformance was identified for this part-lot number combination.At this point, 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).Associated medwatch report number: 1221934-2018-53962.

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.If information is obtained that was not available for the medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).The expiration date is currently unavailable.

Event Description

Implants were not attached to the suture.There were no patient consequences.Is the information being submitted for this complaint all the details that are known/available regarding this event? : yes.Additional information received on 10/11/2018.There was a surgical delay of 15 minutes.The event occurred intraoperatively.The case was completed with another truespan.An alternative product was readily available.Implant was not correctly deployed.The implant was not broken in two or more pieces.The bone quality was no meniscal repair.The surgeon was off axis.The same bone hole was used tom complete the procedure.The implant was removed.

• Brand Name: TRUESPAN 24 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: 7702123
• MDR Text Key: 114415205
• Report Number: 1221934-2018-53960
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 10886705026029
• UDI-Public: 10886705026029
• 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,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 228152
• Device Lot Number: L563214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2018
• Date Manufacturer Received: 11/02/2018
• Patient Sequence Number: 1