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Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Physical Asymmetry (4573)
Event Type  Injury  
Manufacturer Narrative
510k: this report is for an unk - constructs: expert tibial nail/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:lee j. , et al (2020) results of intramedullary nailing for distal metaphyseal intra-articular fractures of tibia, journal of the korean fracture society, volume 33, no. 4 , pages 1-8((b)(6)) this retrospective study aims to assess the postoperative outcome to determine using intramedullary nails for distal tibia fractures involving the articular surface that corresponded to ao 43 b and 43 c1 treatment method is comparable to the conventional method that uses minimally invasive metal plate for internal fixation. From november 2009 to november 2018, intramedullary nail insertion was performed for a total of 105 cases of distal tibia fractures involving the articular surface that corresponded to ao 43 types b and 43 c1. Among these patients, 24 cases (8 females, 16 males) with average age of 50 ± 15. 3 years (average ± standard deviation, range 23-77 years), with minimum follow-up of 12 months were evaluated using a retrospective study analysis. Nails used in the study consisted of expert tibial nails (synthes, oberdorf, switzerland) or zimmer natural nails (zimmer, warsaw, in, usa). Znn was used in 10 of 24 cases and etn was used in the remaining 14 cases. In 8 of 14 cases using etn, the angular stable locking system screw depuy synthes, raynham, ma, usa) was used. An average of 2. 17 ± 0. 92 (range 1-3) distal locking screws were used and interference screws were used in 10 cases, in which the average was 1. 4 ± 0. 77 (range 1-2). In 8 cases, cannulated screws were used for additional fixation of bone fragments, in which the average was 1. 5 ± 0. 93 (range 1-3). The average follow-up period was 12. 5 ± 2. 45 months (range 12-24 months). The following complications were reported as follows: 2 cases of superficial wound infection occurred, and the wound was healed only with conservative treatment without transplant treatment after the use of antibiotics and disinfection, the wound showed improvement. 4 case decreased range of motion in the ankle joint was shown, and it was found that the dorsiflexion was mean 2. 5° ± 2. 89° (range 0°-5°) and plantar flexion was mean 12. 5° ± 2. 89° (range 10°-15°) with the lowest omas score of 70. This report is for an unknown synthes expert tibial nails and unknown synthes angular stable locking system screw. This report is for one (1) unk - constructs: expert tibial nail. This is report 1 of 2 for complaint (b)(4).
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Manufacturer (Section D)
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
MDR Report Key12129784
MDR Text Key269731101
Report Number8030965-2021-05589
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeSP
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 06/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/24/2021
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?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 07/07/2021 Patient Sequence Number: 1