MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: CLAVICLE HOOK PLATE/SCREWS; SCREW,FIXATION,BONE

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

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

Device report from synthes reports an event in korea, south as follows: this report is being filed after the review of the following journal article: yoo y.S., (2021) comparison of hook plate fixation versus arthroscopic coracoclavicular fixation using multiple soft anchor knots for the treatment of acute high-grade acromioclavicular joint dislocations, the journal of arthroscopic and related surgery, vol 37, no 5 : pp 1414-1423 (b)(6).Https://doi.Org/10.1016/j.Arthro.2020.12.189 this study aims to compare the clinical and radiologic outcomes of arthroscopically assisted coracoclavicular (cc) fixation using multiple soft anchor knots versus hook plate fixation in patients with acute high-grade rockwood type iii and v acromioclavicular (ac) joint dislocations.From february 2016 to march 2018, 38 patients underwent surgical treatment in our hospital by a single senior surgeon (y-s.Y.) for traumatic ac joint dislocation.After applying the exclusion criteria, 22 patients were finally enrolled.The ar technique was performed in 12 patients (8 males and 4 females) with mean age of 42.8-5.4 years ( range 34-57) where (y-knot flex all-suture anchor system, conmed linvatec, (b)(6) was used.Ho group fixation was performed in 10 patients (7 males and 3 females) with mean age of 44.4 - 6.5 years (range 30-61) where hook plate (synthes, (b)(6) was used.All patients enrolled in this study had a minimum follow-up period of 24 months after surgery and were evaluated by clinical and radiologic examinations.In the ho group, the hook plate was removed 16 to 20 weeks after surgery.The average follow-up period for this study was 31.5 months (range, 24.0-62.0 months).The following complications were reported: (4/10) of the patients in the ho group had ac joint arthritic change.(figure 4).Only 70% (8/10 patients) horizontal stability was maintained in the ho group.This report is for an unknown synthes hook plate.A copy of the literature article is being submitted with this medwatch.This report is for one (1) unknown extraction instrument.This is report 1 of 1 for (b)94).

Manufacturer Narrative

(b)(4).Additional narrative: this report is for an unk constructs: clavicle hook 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 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.

• Brand Name: UNK - CONSTRUCTS: CLAVICLE HOOK PLATE/SCREWS
• Type of Device: SCREW,FIXATION,BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12666648
• MDR Text Key: 284376545
• Report Number: 8030965-2021-08825
• 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,literature
• Type of Report: Initial
• Report Date: 09/22/2021

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: 09/22/2021
• Initial Date FDA Received: 10/20/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention