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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: TRAUMA PLATE, FIXATION, BONE

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SYNTHES GMBH UNK - PLATES: TRAUMA PLATE, FIXATION, BONE Back to Search Results
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/28/2021
Event Type  malfunction  
Manufacturer Narrative
This report is for an unk - plates: trauma/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. Reporter is a j&j employee. 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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, while adjusting the screw, the tip of the driver shaft broke and the drill guide would not fit into any 1. 5 plate. Procedure was completed successfully without any surgical delay. Concomitant devices reported: unknown plates (part# unknown, lot# unknown, quantity unknown), unknown screws (part# unknown, lot# unknown, quantity unknown). This report is for one (1) unk - plates: trauma. This is report 1 of 3 for complaint (b)(4).
 
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Brand NameUNK - PLATES: TRAUMA
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key13087738
MDR Text Key282783153
Report Number8030965-2021-10469
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeCO
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 12/27/2021 Patient Sequence Number: 1
Treatment
LCP DRILL SLEEVE 1.5 F/DRILL BIT Ø1.1; SCRDRIVER SHAFT 1.5 T4 SHORT SELF-HOLD; UNK - SCREWS: TRAUMA
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