MAUDE Adverse Event Report: TORNIER INC PITON¿ ANCHOR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number SMK000101

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/09/2021

Event Type  malfunction  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.

Event Description

It was reported that the patient underwent an open shoulder surgery - pectoralis major tendon repair.The surgeon planned to use 3 piton anchors to repair the ruptured tendon, proximal humerus.First anchor deployed, as per standard technique, without incident.Surgeon commented that patient's bone "was very hard".2nd hole made using awl, it was very difficult to remove awl.The suture (already through tendon) loaded into anchor.Surgeon kept this suture under tension during anchor insertion and on deployment of anchor, one suture limb was cut.A 3rd hole was made, inferior to previous 2; suture loaded into this 3rd anchor, awl used, anchor deployed - however surgeon noted that the anchor was not fully inserted into hole, and the anchor was deployed mid-bone (not fully inserted).The surgeon unable to remove anchor, decided to push anchor fully into hole using small bone punch, which was successful.Surgeon decided to implant a 4th anchor using the 3.5 awl to make hole - bone still very hard and the surgeon struggled to seat anchor fully into hole.The anchor "jammed" half way in; the surgeon removed the anchor with difficulty.On inspection, this anchor had been damaged on insertion, the outer sleeve at tip had been bent back, trapping suture limbs and unable to be removed.The suture limbs were cut.Surgeon decided to enlarge the hole, using a 3.8mm drill bit.A 5th anchor was implanted, and deployed - however, when surgeon applied traction on suture limbs, to set the anchor, it pulled out of the hole, with several of the anchor's "barbs" bent in odd way.Surgeon expressed disappointment at the course of events.To complete the repair, the surgeon elected to use a competitor product (arthrex "pec button"), which completed the tendon repair - surgeon happy with resultant repair.

Manufacturer Narrative

The reported event could be confirmed.On the picture provided, the failure mode noted in the event description can be confirmed.The photo shows the wings of the anchor have activated still attached to the sutures.The insertion shaft appears to be in good condition for this device.The device failed to remain in the patient¿s bone.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by failure to insert the anchor below the cortical surface of the bone prior to deployment of the anchor.It was stated in the event description several times that the patient had ¿hard bone¿.This could be a contributing factor of why the surgeon was unable to get the anchor in deep enough prior to deployment.If any additional information is provided, the investigation will be reassessed.

Event Description

It was reported that the patient underwent an open shoulder surgery - pectoralis major tendon repair.The surgeon planned to use 3 piton anchors to repair the ruptured tendon, proximal humerus.First anchor deployed, as per standard technique, without incident.Surgeon commented that patient's bone "was very hard".2nd hole made using awl, it was very difficult to remove awl.The suture (already through tendon) loaded into anchor.Surgeon kept this suture under tension during anchor insertion and on deployment of anchor, one suture limb was cut.A 3rd hole was made, inferior to previous 2; suture loaded into this 3rd anchor, awl used, anchor deployed.However surgeon noted that the anchor was not fully inserted into hole, and the anchor was deployed mid-bone (not fully inserted).The surgeon unable to remove anchor, decided to push anchor fully into hole using small bone punch, which was successful.Surgeon decided to implant a 4th anchor using the 3.5 awl to make hole.Bone still very hard and the surgeon struggled to seat anchor fully into hole.The anchor "jammed" half way in; the surgeon removed the anchor with difficulty.On inspection, this anchor had been damaged on insertion, the outer sleeve at tip had been bent back, trapping suture limbs and unable to be removed.The suture limbs were cut.Surgeon decided to enlarge the hole, using a 3.8mm drill bit.A 5th anchor was implanted, and deployed.However, when surgeon applied traction on suture limbs, to set the anchor, it pulled out of the hole, with several of the anchor's "barbs" bent in odd way.Surgeon expressed disappointment at the course of events.To complete the repair, the surgeon elected to use a competitor product (arthrex "pec button"), which completed the tendon repair - surgeon happy with resultant repair.

• Brand Name: PITON¿ ANCHOR
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer Contact: nathe hendricks ; 1023 cherry rd; memphis, TN 38117 ; 9014516318
• MDR Report Key: 12131484
• MDR Text Key: 263549200
• Report Number: 3004983210-2021-00053
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00846832000036
• UDI-Public: 00846832000036
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K091870
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/21/2021

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: 01/05/2024
• Device Model Number: SMK000101
• Device Catalogue Number: SMK000101
• Device Lot Number: AH59931
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/09/2021
• Initial Date FDA Received: 07/07/2021
• Supplement Dates Manufacturer Received: 11/25/2021
• Supplement Dates FDA Received: 12/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 22 YR
• Patient Sex: Male