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Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Nerve Damage (1979); Pain (1994); Skin Irritation (2076); No Code Available (3191)
Event Date 02/28/2019
Event Type  Injury  
Manufacturer Narrative
510k: this report is for an unknown constructs: 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. 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. (b)(4). 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
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: hodel s. , et al (2019) factors predicting adverse outcome in complete intra-articular distal radius fractures, european journal of trauma and emergency surgery , pages 1-7 (switzerland). This retrospective study aims to assess functional and radiological outcome in complete intra-articular distal radius fractures (ao 23 c2¿3) and the secondary aim was to assess potential risk factors for adverse functional outcome. Between january 2012 and june 2016,a total of 87 patients (29 males and 58 females) with a mean age of 57 years (range 18¿92) with an intra-articular distal radius fracture who underwent surgery were included in the study. Definitive fixation was performed with a volar or dorsal locking-compression plate system (synthes©, oberdorf, switzerland). Surgery was performed either through a volar (n
71) , a dorsal (n
2) or a combined approach (n
12). Two patients were treated only with a joint spanning external fixation due to severe fracture comminution in osteoporotic patients. 18 patients immobilization in a cast or external fixator (synthes©, oberdorf, switzerland) was performed either in cases of concomitant injuries, patient¿s incompliance or when orif was not considered stable enough for early active range of motion for a median of 45 days (range 14¿72 days). All patients were evaluated radiographically and clinically at 6 weeks,3 months, 6 months and 1 year after surgery. The following complications were reported as follows: postoperative complications occurred in a total of three patients who needed a revision surgery. An early complication was a carpal tunnel syndrome (cts), which was treated with a surgical carpal tunnel release (ctr). Two patients had a late complication; one screw dislocation, which was removed surgically, and one rupture of the extensor pollicis longus (epl) tendon which was reconstructed. Two of the complications occurred in patients who underwent temporary external fixation and staged orif (screw mal positioning and cts). The epl tendon rupture occurred in a patient who underwent direct orif with a volar approach. A crps was diagnosed in six patients. Flexor tendon irritations occurred in nine patients and extensor tendon irritations in nine patients. Postoperative removal of osteosynthesis material was performed in 27 after a volar approach and in 8 after a dorsal or combined approach. Two patients had a late complication; one screw dislocation, which was removed surgically. (one of the two patients who had complication who underwent temporary external fixation and staged orif). This report is for an unknown synthes volar or dorsal locking-compression plate system. This is report 2 of 5 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 Key10309504
MDR Text Key199988542
Report Number8030965-2020-05147
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeSZ
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 07/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2020
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 Received07/15/2020
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: 07/22/2020 Patient Sequence Number: 1