MAUDE Adverse Event Report: SYNTHES GMBH LCP CLAVIC-HOOKPL 3.5 R 5HO HOOK 18 SST; PLATE, FIXATION, BONE

Catalog Number 241.086

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

Patient Problems Nerve Damage (1979); Pain (1994)

Event Type  Injury  

Event Description

Device report from synthes reports an event in (b)(6) as follows: this report is being filed after the review of the following journal article: arismendi a., (2020) subacute acromioclavicular dislocation after basal coracoid process fracture: indirect reduction without open reduction and internal fixation a case report, the journal of bone and joint surgery volume 10, pages 1-5 (colombia).This study presents a case report of an unusual case of secondary subacute occurrence of ac grade iii complete dislocation 1 week after an isolated basal undisplaced hinged cp fracture had been diagnosed and conservative treatment had been initiated.A case of a (b)(6) year-old man suffered a direct trauma to his right shoulder when he fell from a horse.During the physical examination, the patient complained of pain and sensitivity in the right shoulder, localized ecchymosis, and restricted range of movement (rom).The radiographic projections and computerized tomography (ct) showed an incomplete nondisplaced hinged fracture at the base of the cp of the right scapula.A conservative treatment with immobilization using a shoulder sling, and analgesics was initiated.One week after the initial trauma, the patient was back at the ed because of spontaneous, intense pain, and evident anatomical deformity at the right ac joint (acj).Right shoulder anteroposterior (ap), axial, and scapular lateral x-ray images showed a type iii ac dislocation of the right shoulder and displaced cp fracture.It was decided to anatomically reduce the ac dislocation with a hook plate and indirectly reduce the cp fracture via cc ligamentotaxis (synthes).The acj was reduced easily and completely using 5 holes and an 18-mm height synthes hook plate, one distal cortical screw, and 2 proximal locked screws.The intraoperative fluoroscopic y-scapular view revealed anatomic cp fracture reduction.Shoulder was immobilized and sling was removed after 2 weeks.Immediate postsurgical x-ray images revealed the anatomic reduction of the acj and the coracoid fracture.Four months after surgery, a ct scan showed persistence of the reduction with complete cp fracture consolidation.The fifth-month follow-up revealed right shoulder complete range of motion with a mild impingement pain due to the presence of the hook plate with perfect rotator cuff strength and a free of pain and clinically stable acj.Radiographical analysis evidenced complete cp healing.Hook plate retrieval was undertaken after this clinical and radiological follow-up.Last clinical and radiological follow-up, 1 year after surgery, evidenced complete radiological cp consolidation, acj anatomic reduction with a pain-free complete range of motion, and normal shoulder strength for deltoid, rotator cuff, and pericapsular muscles.The following complications were reported: the fifth-month follow-up revealed right shoulder complete range of motion with a mild impingement pain due to the presence of the hook plate with perfect rotator cuff strength and a free of pain and clinically stable acj.Radiographical analysis evidenced complete cp healing.Hook plate retrieval was undertaken after this clinical and radiological follow-up.This report is for an unknown synthes 5 holes and an 18-mm height hook plate, one distal cortical screw, and 2 proximal locked screws.This report is for (1) unk - plates: hook plate.This is report 1 of 4 for complaint (b)(4).

Manufacturer Narrative

This report is for an unk - plates: hook plate/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 as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.The 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.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.

• Brand Name: LCP CLAVIC-HOOKPL 3.5 R 5HO HOOK 18 SST
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12668028
• MDR Text Key: 281013771
• Report Number: 8030965-2021-08830
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 241.086
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2021
• 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