MAUDE Adverse Event Report: DEPUY MITEK LLC US UNKNOWN GII ANCHOR; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number UNK GII ANCHOR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Weakness (2145); Hypoesthesia (2352)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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.[(b)(4)].

Event Description

This report is being filed after the review of the following journal article: s.E.Aldridge, et al, 2012 ¿incomplete avulsion of the proximal insertion of the hamstring, outcome two years following surgical repair¿, the journal of bone and joint surgery, vol.94-b, no.5 pages 660-662 (united kingdom).The study emphasizes the repair of partial avulsion of the hamstring origin from the ischium.It provides follow-up of consecutive patients for at least two years, and has both subjective outcomes, in the form of a questionnaire, and objective outcomes in the form of strength testing and return to sport.Between january 2003 and may 2008, there were ten men and 13 women, with a mean age of 42 years (25 to 58), and there were 12 right- and 11 left-sided injuries.A partial avulsion was defined as a tear of the origin of the hamstring whereby some but not all of the fibres were avulsed from the ischium, leaving an intact portion of the bone-tendon complex.The cause of the injury was most frequently running (six patients), performing the splits (five patients) and waterskiing (four patients), and the rest occurred during ball games, long-jumping, dancing and walking.The indication for surgery was a diagnosis of incomplete avulsion confirmed by mri, with pain and loss of function severe enough to limit activity.Most patients had undertaken an extensive trial of conservative treatment including physiotherapy, acupuncture, and plateletrich plasma (prp) injections prior to surgery, which had failed.Surgery is performed under general anaesthesia with the patient positioned prone and with a pillow under the pelvis.The leg is prepared and draped to allow access to the posterior buttock and free movement of the knee.A longitudinal incision is made with the ischium as the proximal landmark.Although a transverse incision has been advocated for approach to the proximal hamstring,'" we routinely use a longitudinal incision as this allows extension of the wound to access distally retracted tendons in the presence of an unrecognized complete avulsion (which was not encountered in this series), and access to the sciatic nerve, which is routinely exposed to avoid injury, as it can be obscured in scar tissue.The inferior aspect of the gluteus maximus is exposed, and blunt dissection underneath this allows positioning of retractors to reveal the fascia overlying the ischial tuberosity and hamstring.Care must be taken to avoid injury to the posterior cutaneous nerve of the thigh.The device involved: superquick anchors with orthocord tails (depuy-mitek, (b)(4)) are inserted into the lateral wall of the ischium and sutures are passed in a modified mason-allen technique through the proximal hamstring tendon, and tied so as to approximate the tendon to the ischium.At review, using a visual analogue scale (vas, 0 to 100), pain while sitting improved from a mean of 40 (0 to 100) to 64 (0 to 100) (p = 0.024), weakness from a mean of 39 (0 to 90) to 76 (7 to 100) (p = 0.0001) and the ability to run from a mean of 24 (0 to 88) to 64 (0 to 95) (p = 0.0001).According to a vas, satisfaction was rated at a mean of 81 (0 to 100) and 20 patients (87%) would have the same procedure again.Hamstring strength measured pre- and post-operatively had improved significantly from a mean of 64% (0% to 95%) to 88% (50% to 114%) compared with the normal side.Complications mentioned in the article were : a total of 12 patients (52%) complained of postoperative symptoms; six had mild hamstring tightness, one had persistent weakness, two had some numbness over the posterior aspect of the leg, and five had persistent pain on sitting.One patient was dissatisfied with the operation and would not undergo it again, and one patient with a satisfaction score of 50% also would not undergo the operation again.These two patients had no improvement in their symptoms but were able to go back to sport at the same level as before the injury.Both had a long interval between injury and surgery (1.3 and 16 years, respectively).Most of these patients with symptomatic incomplete hamstring avulsions unresponsive to conservative treatment had an improved outcome after surgical repair.

• Brand Name: UNKNOWN GII ANCHOR
• Type of Device: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 9134229
• MDR Text Key: 166219575
• Report Number: 1221934-2019-58656
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK GII ANCHOR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention