MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - CONSTRUCTS: DYNAMIC COMPRESSION PLATE/SCREWS; PLATE,FIXATION,BONE

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

Patient Problems Ossification (1428); Arthritis (1723)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown constructs: dynamic compression plate/screws/unknown lot.Part and lot numbers are unknown; udi 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.

Event Description

This report is being filed after the review of the following journal article: lindenhovius a., et al (2008)long-term outcome of operatively treated fracture-dislocations of the olecranon,journal of orthopedic trauma, volume 22, pages 325¿331 (usa).This study aims to document the long-term outcome of operative treatment of anterior and posterior olecranon fracture dislocations and to compare the early and late results of treatment of anterior and posterior injuries to test the hypothesis that flexion arc deteriorates over time.Between 1974 and 1994, 43 skeletally mature patients had an anterior or posterior fracture dislocation of the olecranon.Of these 43 patients, 14 were deceased, 6 could not be located, and 3 declined participation, leaving 20 patients (13 males,7 females) with a mean age of 30 years (range, 14 to 53 years) at the time of injury for evaluation.Plate and screw fixation was used in 11 patients (4 with one third tubular plates, and 6 with a 3.5-mm dynamic compression plate; in one patient, both a 3.5-mm dynamic compression plate and a tension band wire was used).In 8 patients, a figure-of-eight tension band wire construct was used.One patient with a complex anterior fracture dislocation was treated with closed reduction, percutaneous temporary transfixation of the radiocapitellar joint with a smooth kirschner wire, and cast immobilization.An early follow-up (fewer than 2 years) was available from the medical record for 15 patients at an average of 14 6 4 months (range, 6 to 24 months) after surgery.The following complications were reported as follows: 14 deceased patients.Seven of these patients (all women) died an average of 15 years (range, 7 to 23 years) after injury; in the other cases, the date of death was unknown.A case of a (b)(6) year old (pt.No.29) who experienced loosening of a one-third tubular plate 2 months after injury healed after repeat internal fixation with a 3.5-mm dynamic compression plate and application of autogenous cancellous bone graft.This patient sustained a refracture 2 weeks after routine implant removal 18 months after the second procedure (5 months after the early follow-up).The refracture was treated with a 3.5-mm dynamic compression plate, and this surgery was complicated by infection.Five patients had symptoms and signs suggestive of ulnar nerve compression at the elbow, which were classified as grade 1 in 3 patients and grade 2 in 2 patients according to the scale of mcgowan.Together with the 2 patients that had already had a subsequent ulnar nerve release, a total of 7 of 20 patients developed an ulnar neuropathy within the study period.One patient that had an elbow contracture release 22 months after the initial procedure had recurrence of heterotopic bone and a flexion arc of only 10 degrees.Another patient had a proximal radioulnar synostosis.One patient that developed a proximal radioulnar synostosis declined surgery.A case of a (b)(6) year old (pt no.3 ) treated with dcp had arthrosis grade 2 post-operatively.A case of a (b)(6) year old (pt no.4 ) treated with dcp had arthrosis grade 1 post-operatively.This patient also had a subsequent elbow contracture release after fracture consolidation (one with excision of heterotopic ossification blocking ulno humeral motion); both procedures took place after the early follow-up.A case of a (b)(6) year old (pt no.7 ) treated with dcp had arthrosis grade 1 post-operatively.A case of a (b)(6) year old (pt no.19 ) treated with dcp had arthrosis grade 1 post-operatively.A case of a (b)(6) year old (pt no.20 ) treated with dcp had arthrosis grade 3 post-operatively.This patient also had signs of ulnar neuropathy had a transposition of the ulnar nerve during the procedure for implant removal (5 weeks before the early follow-up in 1 patient, and there was no early follow-up in 1 patient).This report is for an unknown synthes 3.5-mm dynamic compression plate (dcp).A copy of the literature article is being submitted with this medwatch.This is report 2 of 5 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: DYNAMIC COMPRESSION PLATE/SCREWS
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11582581
• MDR Text Key: 242777852
• Report Number: 2939274-2021-01561
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2021
• 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?: Yes
• Date Manufacturer Received: 03/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention