MAUDE Adverse Event Report: DEPUY MITEK SUPER QUICKANCHOR+ DS W/#2 ORTHOCORD; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number 222984

Device Problems Break (1069); Material Rupture (1546)

Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 08/21/2017

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi:1221934-2017-10540.Associated mdw: 1221934-2017-10539.

Event Description

The affiliate reported via email that the suture broke during a re-insertion distal biceps procedure.First pick another 222984 but same problem.Than pick a different product, gii anchor 222983 and suture didn't break.The suture broke.Remove all suture.Anchor without suture stay in the bone.There were no adverse patient event but there was a 10 minute delay.Did delay result in adverse event? no.How long was delay? 10 minutes.When was the issue detected? was there a resulting surgical delay - how long? yes, 10 minutes.Was the procedure able to be completed? yes, with a gii anchor.Were alternatives readily available? yes.Any patient impact? no.What was the reason for the 10 minute delay? bring a new anchor to the operating room.When was the issue detected? during making the knots.Were the two first anchors that the suture broke removed or left in the patient unused? left in the patient.Was a new bone hole created to complete the procedure with the gii anchor? yes.Where on the suture did the break occur? don¿t know.Was the suture in contact with an instrument during breakage? no.When in the procedure did the break occur? during making the knots.What suture cutter was used? scissor.

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.Investigation summary: the complaint device is not being returned as it was left in the patient, therefore unavailable for a physical evaluation.Review of the device history record indicated that this batch of product was processed without incident; therefore there is no evidence of manufacturing anomalies on the paperwork reviewed.Further, a review into the depuy synthes mitek complaints system revealed no other complaints of any kind for this lot of devices that were released to distribution.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, 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: the batch review l374561 showed that the (b)(4) devices were conformed to in process and finished goods specifications when released to stock on may 15, 2017.Expiration date: march 31, 2020 (according to retained labels).No nc was opened.Device history batch: null.Device history review: null.Udi: (b)(4).

Event Description

The affiliate reported via email that the suture broke during a re-insertion distal biceps procedure.First pick another 222984 but same problem.Than pick a different product, gii anchor 222983 and suture didn't break.The suture broke.Remove all suture.Anchor without suture stay in the bone.There were no adverse patient event but there was a 10 minute delay.The following additional information was received via email from the affiliate on 09-04-17: the affiliate reported that the failure occurred during making the knots and that the two first anchors that the suture broke were left in the patient unused.A new bone hole was created to complete the procedure.No information could be provided on where on the suture did it break.The suture was not in contact with an instrument when it broke.The suture broke when making the knots and scissor were used as the suture cutter.

• Brand Name: SUPER QUICKANCHOR+ DS W/#2 ORTHOCORD
• Type of Device: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS SARL TOLLER MITEK; chemin blanc 38; le locle MA 2400 ; SZ 2400
• Manufacturer Contact: jennifer lawrence ; 325 paramount drive; raynham, MA 02767 ; 5089776860
• MDR Report Key: 6895784
• MDR Text Key: 87447825
• Report Number: 1221934-2017-10540
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• PMA/PMN Number: K052631
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/28/2017,03/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 222984
• Device Lot Number: L374561
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 08/28/2017
• Date Manufacturer Received: 03/19/2018
• Date Device Manufactured: 05/05/2017
• 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 Outcome(s): Other