MAUDE Adverse Event Report: ETHICON INC. PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT; SUTURE, SURGICAL, ABSORBABLE

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

Patient Problems Pain (1994); Loss of Range of Motion (2032); Deformity/ Disfigurement (2360); Ambulation Difficulties (2544); Muscle/Tendon Damage (4532)

Event Date 10/23/2020

Event Type  Injury  

Event Description

Title: is shortening of tibialis anterior in addition to calf muscle lengthening required to improve the active dorsal extension of the ankle joint in patients with cerebral palsy? this retrospective study aims to investigate the effect of shortening of tibialis anterior tendon (tats) combined with muscle lengthening procedure (cmlp) against the effect of muscle lengthening procedure (cmlp) alone both in unilateral and bilateral cerebral palsy (cp).Between 2010 and 2017, complete clinical and gait analysis data were available in 72 patients who underwent the treatment for equinus deformity.Of these 28 subjects were excluded (patients unable to walk free, recurrent equinus deformity and pain at the time to follow-up).In all 44 feet in 44 patients were included in the study.Of these, 24 feet (24 patients) belonged to unilateral and 20 feet (20 patients) to bilateral cerebral palsy (cp).The male:female ratio was 15:9 in unilateral and 12:8 in bilateral cerebral palsy (cp) groups respectively.The average age of the patients at surgery was 12.6 years and 11.6 years in the unilateral cerebral palsy (cp) group and 12.2 years and 11.8 years in the bilateral cerebral palsy (cp) group with and without shortening of tibialis anterior tendon (tats) respectively.The study patients were divided based on their diagnosis into unilateral cerebral palsy (cp) and bilateral cerebral palsy (cp).Each group was further divided into 2 subgroups: muscle lengthening procedure (cmlp) alone and those receiving shortening of the tibialis anterior tendon (tats) in addition to muscle lengthening procedure tibialis anterior tendon (cmlptats).Each subgroup ( muscle lengthening procedure and muscle lengthening procedure with shortening of the tibialis anterior tendon) included 12 feet (patients).During surgery, the tibialis anterior tendon (tats) was done at its insertion by double reefing of the tendon and anchoring to the bone using a non-absorbable monofilament 1.0 polydioxanone suture (pds ethicon®) with the foot held in 90¿.The mean follow up time was 19.7 (±3.2) months.Reported complications included: of the 72 patients who underwent the treatment (n=28) 28 subjects were excluded (patients unable to walk free, recurrent equinus deformity and pain at the time to follow-up).(n=?)no significant improvement in the strength of the ta muscle was seen following tibialis anterior tendon (tats) in the unilateral group.(n=?) the strength of the tibialis anterior muscle did not improve at follow-up in the bilateral group.(n=?) the ankle range of movement of ankle dorsiflexion in swing phase (deswing) decreased by 4.3¿ in unilateral and decreased by 6¿ in bilateral cerebral palsy following shortening of the tibialis anterior tendon (tats) and muscle lengthening procedure (cmlp).(n=?) the movement analysis profile (map) was considerably reduced in unilateral patients.Non-responders to surgery were noted in this study; (n=1) 1 with muscle lengthening procedure (cmlp) and shortening of the tibialis anterior tendon (tats).In these feet only the distance improved.It was concluded, that the recovery of the de thereby the position of the foot and the rom of deswing are primarily due to the release of the ¿tether effect¿ of the calf muscle.However the credit of this statement goes to (b)(6) who suspected this effect as a cause for the equinus gait [9].We found in our study group, the tats did not add much to the improvement of dorsiflexion of ankle in those patients showing a swing phase dorsiflexion activity during gait.The role of this surgery when ta is paralytic is questionable as they may remain as non-responders.

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Does the surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Patient demographics? this report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.(b)(4).The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation: gait & posture 83 (2021) 210¿216 https://doi.Org/10.1016/j.Gaitpost.2020.10.019.

• Brand Name: PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12705703
• MDR Text Key: 284312921
• Report Number: 2210968-2021-10438
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• PMA/PMN Number: N18331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention