MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: SMALL FRAGMENT LCP; PROSTHESIS, RIB REPLACEMENT

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

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Date 11/30/2020

Event Type  Injury  

Manufacturer Narrative

Additional narrative: this report is for an unk constructs: small fragment lcp/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: shinohara i., et al (2021) floating forearm associated with terrible triad injury and essex-lopresti injury: a case report and literature review, jses international volume 5, pages 320e327 ((b)(6)) https://doi.Org/10.1016/j.Jseint.2020.09.017 this study presents a case report of a patient of floating forearm associated with both terrible triad injury (tti) and essex-lopresti injury (eli).A case of a (b)(6) man presented with right elbow pain after a fall from a height of three meters.There was no complaint of pain around the right wrist.Physical examination revealed swelling, tenderness, and a wound on the medial side of the right elbow.Swelling and tenderness were unclear around the right wrist.The extremity was neurovascularly intact.Plain radiographs revealed posterior dislocation of the elbow with radial head comminuted fracture.Three-dimensional and plain computed tomography of the forearm revealed a coronoid tip fracture, displaced radial head fracture, distal radius avulsion fracture, and ipsilateral drug incompatibility.The small coronoid tip fragment (regan-morrey type ia, o¿driscoll type i, subtype 1) was located anteriorly to the elbow joint.The radial head showed a three-part fracture with a shortened radial length (mason-morrey type iii).The distal radial fracture presented as a dorsal ulnar avulsion fracture, partially extending to the drug.An open fracture, immediate surgery was performed.An external fixator was positioned to stabilize the elbow joint, particularly because the elbow joint was easily redislocated after reduction.Eleven days after the injury, in accordance with pugh¿s strategy for the tti, plate (lcp proximal radius plates 2.4, synthes, (b)(6), usa) and screw (dtj screw, meira, (b)(6)) fixation for the radial head fracture, suture lasso technique for the coronoid tip fracture using nonabsorbable suture material (fiberwire, arthrex, (b)(6), usa), and repairs of the medial and lateral collateral ligaments using suture anchors (corkscrew anchors, arthrex, (b)(6), usa) were performed.Subsequently, screw (asnis micro, stryker) fixation for the distal radius avulsion fracture and restabilization of the unstable drug were performed.Considering bipolar dislocation, external fixation of the elbow was maintained in the neutral position for 3 weeks.The patient then started range of motion exercises with a functional elbow brace.The k-wires used for drug fixation and perilunate stabilization were removed 6 weeks after surgery.Three months after the injury, an artificial radial head replacement (evolve, microport, shanghai, china) was performed due to breakage of the screw of the radial head plate, displacement of the anterior part of the radial head fracture and incompatibility of the radiocapiteller joint.Although the function of the elbow improved, instability of drug worsened over time.One and a half year after the injury, owing to residual painful wrist joint dysfunction, ulnar shortening osteotomy and suture-button reconstruction of the iom using tight-rope (arthrex, (b)(6), usa) were performed.The ulna was shortened about 10 mm and fixed with a lcp-small plate (lcp-small plate, synthes, (b)(6), usa).Tight-rope was inserted from 10 cm proximal to the ulnar styloid process to 17 cm proximal to the radial styloid process; thereafter, the rope was tightened at the maximum supination position.At the time of final follow-up, three years after the injury, the elbow was stable with occasional mild pain; the extension of the left elbow remained limited at 25 degrees, whereas flexion was at 135 degrees.The wrist was also stable with occasional mild pain with flexion (45 degrees), extension (70 degrees), pronation (70 degrees), and supination (50 degrees).This report is for an unknown synthes lcp proximal radius plates 2.4 and unknown synthes lcp-small plate) a copy of the literature article is being submitted with this medwatch.This report is for one (1) unk - constructs: small fragment lcp.This is report 1 of 1 for complaint (b)(4).

• Brand Name: UNK - CONSTRUCTS: SMALL FRAGMENT LCP
• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12723253
• MDR Text Key: 284476439
• Report Number: 8030965-2021-09142
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial
• Report Date: 10/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/04/2021
• Initial Date FDA Received: 10/29/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention