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Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Loss of Range of Motion (2032); Swelling (2091)
Event Date 04/27/2018
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown 2. 4mm va lcp volar rim distal radius 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. 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. (b)(4).
Event Description
This report is being filed after the review of the following journal article; uemura, t. Et al (2018) flexor pollicis longus tendon rupture by sandwiched underlying volar locking plate and distal radius, journal of medical ultrasonics (2018) 45:647¿651 (japan). The present article reports a (b)(6) year-old man who fell from a stepladder and sustained a right distal radius fracture. He underwent volar locking plate fixation surgery through a trans-flexor carpi radialis approach without minimally invasive surgery at another hospital. Fractures were fixed using variable angle-lcp two-column distal radius plates 2. 4, narrow (depuy synthes japan, japan). The following complications were reported as follows: the (b)(6) year-old male patient experienced wrist pain and swelling, like complex regional pain syndrome, which remained after surgery. He was continuously treated with medication and rehabilitation therapy, although he had noticed difficulty in right thumb movement immediately after the operation. Four months after the operation, wrist pain and swelling improved, but he was referred to the hospital because he was consistently unable to flex the interphalangeal joint of his right thumb. The hospital performed ultrasonography examination and found the pathological damage of the fpl tendon and during passive flexion of the thumb, slight movement of the slack fpl tendon was visibly only distal to the distal rim of the plate, in which a distal locking screw was observed clearly, but obviously diminished proximally in real-time ultrasound imaging. Intraoperatively, the fpl tendon was found embedded entirely under the plate, and the distal locking screw penetrated the tendon. The proximal stump of the fpl tendon was shortened proximally through the window of the plate and was clearly observed on the plate. The screws and plate were removed. After debridement of the proximal stump of the fpl tendon, 4-cm tendon defects were repaired using interlacing sutures. At follow-up 1 year later, he was able to flex his thumb actively in the same manner as he could prior to the injury. This report is for an unknown 2. 4mm va lcp volar rim distal radius plate. This is report 1 of 2 for (b)(4).
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Manufacturer (Section D)
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
MDR Report Key8197827
MDR Text Key131479095
Report Number8030965-2018-59256
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/26/2018
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 Received11/30/2018
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: 12/26/2018 Patient Sequence Number: 1