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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH DEPTH GAUGE FOR 3.5MM CORTEX SCREWS GAUGE, DEPTH

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SYNTHES GMBH DEPTH GAUGE FOR 3.5MM CORTEX SCREWS GAUGE, DEPTH Back to Search Results
Catalog Number 319.091
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/28/2021
Event Type  malfunction  
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021 the clamping sleeve does not take the screw easily and depth gauge does not slide easily making measurement difficult. This report is for one (1) depth gauge for 3. 5mm cortex screws. This is report 2 of 2 for complaint (b)(4).
 
Manufacturer Narrative
Reporter is a synthes employee. Part # 319. 091, lot # h762606, manufacturing site: (b)(4), supplier: synthes usa hq, inc, release to warehouse date: may 7, 2019. A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified. Visual inspection: the complaint devices depth gauge for cortex screws (product code: 319. 091, lot number: h762606) was returned to customer quality (cq) west chester for investigation. During visual inspection, the depth gauge needle appeared bent and the slider had scratches consistent with usage. Functional test: a functional test of assembling and disassembling the body of the depth gauge over the slider was performed. During the test, it was observed that the body felt tight against the slider when sliding up and down. The body was found scratching the slider during operation. Can the complaint be replicated with the returned device(s)? yes, the complaint condition can be replicated during functional test. Dimensional inspection: the inner diameter of the two extremities of the depth gauge body measured dimension was conforming. Measuring device used: caliper. Document/specification review: based on the date of manufacture, the current and manufactured version of drawing were reviewed. Depth gauge for 3. 5mm pelvic screws, body depth gauge, slider asm, depth gauge. Complaint confirmed: yes, the complaint condition can be confirmed during physical device investigation. Conclusion: the depth gauge body and slider were creating friction when sliding. The gauge needle orientation was not correct and appeared to be bent. This could have reason for the complaint condition. Hence, the complaint was confirmed. A definitive assignable root cause could not be determined from the available 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 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.
 
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Brand NameDEPTH GAUGE FOR 3.5MM CORTEX SCREWS
Type of DeviceGAUGE, DEPTH
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
SYNTHES SELZACH
bohackerweg 5
selzach 2545
SZ 2545
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12821623
MDR Text Key280834655
Report Number8030965-2021-09549
Device Sequence Number1
Product Code HTJ
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
EXEMPT
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
Report Date 08/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number319.091
Device Lot NumberH762606
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/25/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/10/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/07/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 11/16/2021 Patient Sequence Number: 1
Treatment
HOLD-SL F/314.070 314.550+314.570; UNK - SCREWS: TRAUMA
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