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Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Post Operative Wound Infection (2446); Muscle/Tendon Damage (4532)
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown distal radius dorsal pi-plate construct/unknown lot. Part and lot number are unknown. Without the specific part number; the udi number and 510-k 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: karlsson e, et al. (2020), combined volar and dorsal plating vs. Volar plating of distal radius fractures. A single-center study of 105 cases, hand surgery and rehabilitation, volume 39, pages 516¿521, (sweden). The purpose of this study was to compare distal radius fractures treated with either a volar locking plate or a combination of a volar t-plate and a dorsal pi-plate in a consecutive series of 105 patients, all treated at a swedish tertiary referral center with 1 year of follow-up. Between august 01, 2010 and december 31, 2011, 105 patients with a distal radius fracture who underwent surgery were included in the study. The patients included had fracture treated with either an unknown synthes 2. 4 mm lcp distal radius system volar locking plate or a combination of an unknown synthes distal radius volar t-plate and an unknown synthes distal radius dorsal pi-plate. A total of 27 patients were treated with a volar plate and the rest 78 patients were treated with a volar and a dorsal plate (combined plating). In the volar plating group, there were 7 males and 20 females with a mean age of 55 years (range 16-77 years). In the combined plating group, there were 23 males and 55 females with a mean age of 56 years (range 23-82 years). In cases with a concomitant ulnar styloid process fracture and distal radioulnar joint instability after fixation of the distal radius fractures, the ulnar styloid process was stabilized using either an unknown synthes ulnar hook plate (10 patients) or an unknown synthes cannulated 3. 0 mm screw with washer (4 patients). A cast was worn for 2 weeks postoperatively, followed by mobilization by a hand therapist using a removable wrist splint. In case of an ulnar styloid process fracture fixed operatively, an above-the-elbow cast was worn for 4 weeks. In case of a scaphoid fracture stabilized operatively, an above-the-elbow cast was worn for 6 weeks. The patients were allowed to use the wrist without a splint, but lifting heavy objects was discouraged for the first 3 months. Complications were reported as follows: volar plate group. 1 patient had a hardware removal. Unknown patients had inferior wrist range of motion and grip strength compared to the uninjured wrist. Combined plating. 18 patients had a hardware removal. 2 patients had tendon ruptures. 1 patient had ruptures of the extensor pollicis longus, extensor carpi radialis longus and extensor carpi radialis brevis tendons; these were treated with a tendon transfer of extensor indicis proprius to extensor pollicis longus and interposition grafting with the palmaris longus tendon to reconstruct the wrist extensors. The other patient had a flexor pollicis longus rupture which was reconstructed with interposition grafting using the palmaris longus tendon. 3 patients had a superficial wound infection that resolved with oral antibiotics and surgical debridement (1 patient). Unknown patients had inferior wrist range of motion and grip strength compared to the uninjured wrist. This report is for the unknown synthes distal radius dorsal pi-plate construct. This report captures the reported events of hardware removal, revision due to tendon ruptures, superficial wound infection and inferior wrist range of motion and grip strength. This is report 2 of 3 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 Key12481952
MDR Text Key271721900
Report Number8030965-2021-07794
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeSW
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/16/2021
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
Date Manufacturer Received11/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 09/16/2021 Patient Sequence Number: 1