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

Model Number 228152

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/10/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).Udi: (b)(4).

Event Description

It was reported that during an unknown procedure an implant was deployed with the truespan 24 degree peek, but when the surgeon pulled the suture the implant came off.The procedure was completed using a replacement.No patient consequence and no surgical delay was reported.No additional information was provided.It was later reported by the affiliate that the device will not 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.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.H10 additional narrative: investigation summary
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> according to the information provided, it was reported that the implant came off.The complaint device is not being returned, therefore unavailable for a physical evaluation.Since the complaint device was not returned, we cannot determine a root cause for the reported failure.If the device is received in the future, we will reopen the complaint and perform the investigation as appropriate.A manufacturing record evaluation was performed for the finished device [4l95709] number, and no non-conformances were identified.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.Device history lot
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> a manufacturing record evaluation was performed for the finished device [4l95709] number, and no non-conformances were identified.

• 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: 9747222
• MDR Text Key: 205510191
• Report Number: 1221934-2020-00668
• 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: foreign
• Type of Report: Initial,Followup
• Report Date: 02/10/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: 228152
• Device Catalogue Number: 228152
• Device Lot Number: 4L95709
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/10/2020
• Initial Date FDA Received: 02/24/2020
• Supplement Dates Manufacturer Received: 03/02/2020
• Supplement Dates FDA Received: 03/03/2020
• Patient Sequence Number: 1