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

Device Problem Material Integrity Problem (2978)

Patient Problem Granuloma (1876)

Event Date 01/23/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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.The single complaint was reported with multiple events.There are no additional details, demographics regarding the additional events.Attempts are being made to clarify 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 author/surgeon believe that ethicon product (pds cord) involved caused and/or contributed to post-operative complications of two cases described in the article (subcutaneous suture granuloma due to prolonged resorption of the bulky knots)? please specify.Does the author/surgeon believe there was any deficiency with the ethicon product (pds cord) used in this procedure/study? please specify.If yes, please provide patient demographics for patients that experienced the post-operative complications (subcutaneous suture granuloma due to prolonged resorption of the bulky knots) and details of events if available.Were these cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Citation: archives of orthopaedic and trauma surgery (2021) 141:1331¿1338.Https://doi.Org/10.1007/s00402-021-03761-y.

Event Description

Title: additional acromioclavicular cerclage limits lateral tilt of the scapula in patients with arthroscopically assisted coracoclavicular ligament reconstruction.The purpose of this study was to compare the clinical and radiological outcomes after acute type iv and v ac-joint dislocations with a standard arthroscopic bi-cortical cc-button fixation reconstruction and a standard cc reconstruction with an additional ac cerclage, to confirm the results obtained in earlier biomechanical studies.A total of 30 male patients (15 patients in each group (cc-repair group and cc + ac-repair group) with acute (less than 3 weeks) ac-dislocations rockwood grade iv and v from 2014 to 2015 underwent arthroscopic bi-cortical cc-ligament reconstruction were included.Patients were assigned to a surgeon depending on the day of clinical presentation.One surgeon used only bi-cortical cc-ligament reconstruction (no-pds group); the other surgeons used an additional pds cerclage with an 8-loop configuration over the ac joint (pds group).Prior to placing the ac drill guide device as described in the cc-repair group, an approximately 2-cm skin incision was made in the course of the ac joint.The ac joint was cleared and any soft tissue interposition was reduced or removed if needed.The 2.4 mm cannulated drill was used to percutaneously drill a hole in the lateral clavicle approximately 15 mm medial to the ac joint in postero-anterior direction parallel to the plane of the ac joint.Subsequently a shuttle wire was inserted to transport a 1.5 mm pds (polydioxanone) cord (ethicon, johnson & johnson, new brunswick, usa).A second drill hole was established through the acromion about 10 mm lateral to the ac joint in an anterio-posterior direction parallel to the plane of the ac joint starting at the anteroinferior margin of the acromion and ending superiorly at the level of the posterior ac joint.The 1.5 mm pds cord was pulled through, resulting in a figure of eight over the ac joint.The ac cerclage was secured with a half hitch that was temporarily clamped with a hemostat to support the reduction of the joint by the mechanical arm holder.In rare cases, the reduction required additional k-wire transfixation to stay in place for correct in-line cc drilling.Subsequently, the cc repair was performed in the above-described fashion.At the end, the knot of the pds cord was secured with 5 half hitches which were placed posteriorly to the joint ac joint.To avoid local irritation.Two patients in the cc + ac-repair group suffered from subcutaneous suture granuloma due to prolonged resorption of the bulky knots of the cerclage at the ac joint.The suture material was, therefore, changed to a non-bioabsorbable tape material (fibertape, arthrex gmbh, munich) with completion of the inclusion phase of the presented study.Reported postop complications included (n=2) subcutaneous suture granuloma due to prolonged resorption of the bulky knots of the cerclage at the ac joint.In conclusion, both the isolated cc reconstruction and the cc reconstruction with an additional ac cerclage showed good clinical results at 2 years¿ follow-up.Ac distances increased in both groups from the post-surgery measurement to the 2-year follow-up, but were generally lower with an additional ac cerclage.Cc distances did not increase significantly over time in both groups.Therefore, the presented data suggest adding a fixation of the ac joint.

• Brand Name: PDS CORD 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: 12313777
• MDR Text Key: 268034792
• Report Number: 2210968-2021-07277
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: N18331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/30/2021
• 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