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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH TI LCP PROX LATERAL TIBIA PL 5 HOLES/140MM/LEFT-STERILE PLATE,FIXATION,BONE

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SYNTHES GMBH TI LCP PROX LATERAL TIBIA PL 5 HOLES/140MM/LEFT-STERILE PLATE,FIXATION,BONE Back to Search Results
Catalog Number 422.221S
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/09/2021
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Complainant part is not expected to be returned for manufacturer review/investigation. The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report. 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

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent for a removal surgery due to bone union. During the removal surgery, the screw head was stripped. The most proximal screw was removed, and the surgeon tried to remove the remaining distal screw with an extraction screw, but it was idled. As a result, the extraction screw was used again, and the screw could be removed. Originally, the patient underwent the surgery for left tibial plateau fracture with the plate and screws on (b)(6) 2020. The removal surgery was completed successfully within 30-minutes delay. The patient outcome was unknown. Concomitant device reported: lcp-plt 4. 5/5. 0 le 5ho l140 tan (part# 422. 221s; lot# 6l20180; quantity: 1). Unknown extraction screw (part# unknown; lot# unknown; quantity: 1). Unknown screwdriver (part# unknown; lot# unknown; quantity: 1). This complaint involves three(3) devices. This report is for (1) ti lcp prox lateral tibia pl 5 holes/140mm/left-sterile. This report is 1 of 4 for (b)(4).

 
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Brand NameTI LCP PROX LATERAL TIBIA PL 5 HOLES/140MM/LEFT-STERILE
Type of DevicePLATE,FIXATION,BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK GRENCHEN (CH)
solothurnstrasse 186
grenchen 2540
SZ 2540
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12287764
MDR Text Key265388572
Report Number8030965-2021-06455
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK052390
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,O
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/09/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/06/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number422.221S
Device LOT Number6L20180
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 Received09/27/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/23/2019
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 08/06/2021 Patient Sequence Number: 1
Treatment
LOCKSCR Ø5 SELF-TAP L44 TAN.; LOCKSCR Ø5 SELF-TAP L44 TAN.; UNK - SCREWS: LOCKING.
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