MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL BIOINTRAFIX TBIAL SH SM 30MM; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number	254629
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).According to the information provided, it was reported that during the unknown surgery,opened the packing (did not use on the patient), noted the end of device was damaged as the attached photo shows.Another device was used to complete the surgery.No additional information could be provided.The complaint device was received in its original packaging.Visual observation reveals that the sheath screw have considerable crack in one corner.The sheath is broken into multiple pieces.The photo provided by the customer only showed the crack in the end of the sheath-screw and it was out of the packaging.Since the condition of the device, this complaint can be confirmed.A manufacturing investigation activity has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.An analysis was made to the packaging and process control during the production as well as the controls have been done, there was no incident.Also, this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the document reviewed.This type of damage had not gone from manufacturing, there are controls in place to visually inspect the product during manufacturing process until packaging.The cause is undetermined.One possible root cause of the reported by the customer could be related to the handling of the packaging; it cannot be conclusively affirmed.Nevertheless, there is no evidence of manufacturing anomalies on the paperwork reviewed.A manufacturing record evaluation was performed for the finished device lot number: 6l29083, 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.
Event or Problem Description
It was reported by the affiliate in china that during an unknown surgery, the biointrafix tbial sh sm 30mm device upon opening the packing, it was noted the end of the device was damaged.During an in-house engineering evaluation, it was determined that the device had a considerable crack in the corner and the sheath was broken into multiple pieces.There was no procedure involved.No additional information was provided.

• Brand Name: BIOINTRAFIX TBIAL SH SM 30MM
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 11004561
• Report Number: 1221934-2020-03862
• Device Sequence Number: 3813944
• Product Code: HWC
• UDI-Device Identifier: 10886705013258
• UDI-Public: 10886705013258
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K032167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/14/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: 254629
• Device Catalogue Number: 254629
• Device Lot Number: 6L29083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2020
• Initial Report FDA Received Date: 12/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1