MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: LCP DISTAL ULNA; PLATE,FIXATION,BONE

Catalog Number UNK - PLATES: LCP DISTAL ULNA

Device Problem Device Slipped (1584)

Patient Problem Non-union Bone Fracture (2369)

Event Date 04/30/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional narrative: g5-510k: this report is for one (1) unknown plates: lcp distal ulna.Part and lot numbers are unknown.Without the specific part and lot number, the udi is not available.Complainant device is not expected to be returned for manufacturer review/investigation.Clinical code injury.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and 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

Device report from synthes (b)(6) reports an event in (b)(6) as follows: this report is being filed after the review of the following journal article: lo c.K., kam w.L., (2019) distal ulnar fracture nonunion management: an uncommon case report, hong kong journal of emergency medicine , vol.26(1) 57¿60 (hong kong) doi: 10.1177/1024907918773963 this study presents a case report of a patient who had isolated distal ulnar fracture that was treated with open reduction and fixation with locking plate which subsequently developed fracture nonunion.A case of 47-year-old, right-hand dominant electrical worker who had an injury of the left wrist by a fallen metal bar at work.Clinical examination revealed swelling and tenderness at the left distal ulna.Anteroposterior and lateral wrist radiographs demonstrated an isolated distal ulnar fracture with displacement.Open reduction was performed using a direct ulnar approach.The fracture was fixed with an (lcp) distal ulnar locking plate using three locking screws distally and two cortical screws proximally.The patient complained of persistent pain at the fracture site and limited forearm rotation at 6-month follow-up.There was no sign of infection and the inflammatory markers were normal.Radiographs of the left wrist showed fracture nonunion with bone loss and implant loosening.The locking plate was found to be loosened and there was a 5-mm fracture gap filled with fibrous tissue.The plate and screws were removed.The distal ulnar head was reduced and fused with the sigmoid notch of the radius using two 3.5-mm cannulated screws.The fracture site was debrided and the proximal bone end was cut short to create a 15-mm pseudoarthrosis gap.A below-elbow splint was applied to protect wrist for 4 weeks.The hand and forearm were then gradually rehabilitated with motion and strengthening exercise under the supervision of a hand therapist.At 2-year follow-up, the patient was pain free and returned to pre-injury level of activity.His left wrist flexion and extension range reached 50° and 40°, respectively.Supination and pronation of the forearm was 80° and 90°, respectively.The grip strength of his left hand was 38 kg, compared to 46 kg on the right side.Radiographic examination reviewed solid fusion of distal radioulnar joint.These impacted products capture this complication: implant loosening.The locking plate was found to be loosened and there was a 5-mm fracture gap filled with fibrous tissue.This report is for an unknown synthes (lcp) distal ulnar locking plate.This report is for one (1) unk - plates: lcp distal ulna.This report is 4 of 6 for pc (b)(4).A copy of the literature article is being submitted with this medwatch.

• Brand Name: UNK - PLATES: LCP DISTAL ULNA
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA
• MDR Report Key: 11711070
• MDR Text Key: 246976936
• Report Number: 8030965-2021-03196
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK - PLATES: LCP DISTAL ULNA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2021
• 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?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR