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

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.

• Brand Name: DEPTH GAUGE FOR 3.5MM CORTEX SCREWS
• Type of Device: GAUGE, 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 Key: 12821623
• MDR Text Key: 280834655
• Report Number: 8030965-2021-09549
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 07611819796928
• UDI-Public: (01)07611819796928
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 319.091
• Device Lot Number: H762606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2021
• Initial Date FDA Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: HOLD-SL F/314.070 314.550+314.570; UNK - SCREWS: TRAUMA
• Patient Sex: Male