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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH SCREW INSERTER ROD,FIXATION,INTRAMEDULLARY

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SYNTHES GMBH SCREW INSERTER ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 03.037.025
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4). Reporter is a j&j sales representative. Investigation summary: investigation flow: damage / device interaction / functional. Visual inspection: the tfna screw inserter (part #: 03. 037. 025, lot #: l142174) was received at us cq. Visual inspection of the complaint device showed no defects with the device. No other issues were identified with the returned device. The complaint can be replicated with the returned device(s). Functional test: a functional assessment was performed on the complaint device with the returned mating device connecscr f/tfna helic blade+scr, part #: 03. 037. 026, lot #: l181947. The devices showed some resistance while assembling/ disassembling due to the stripped threads of the mating device (part #: 03. 037. 026) and were not assemble/ disassemble as intended. Dimensional inspection: dimensional inspection was not performed as there was no evidence of damage. Document/specification review: based on the date of manufacture the following drawings, reflecting the current and manufactured revision were reviewed. The complaint was confirmed. Investigation conclusion: this complaint is not confirmed as there were no bent features observed with the device. However, the damaged threads of the mating device caused device interaction issue. No definitive root cause could be determined based on the provided information. There was no indication that a design or manufacturing issue contributed to the complaint. Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed. Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities. Device history lot: part: 03. 037. 025, lot: l142174, manufacturing site: (b)(4), release to warehouse date: dec. 07, 2016. A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified. 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 on an unknown date that the instrument was found bent upon inspection while is in sales call. There was no surgery and patient involvement are reported. This complaint involves two (2) devices. This report is for (1) screw inserter. This report is 1 of 1 (b)(4).
 
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Brand NameSCREW INSERTER
Type of DeviceROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK BETTLACH (CH)
muracherstrasse 3
bettlach 2544
SZ 2544
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key11815503
MDR Text Key250771413
Report Number8030965-2021-03885
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K131548
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.037.025
Device Lot NumberL142174
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/30/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/06/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/07/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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