MAUDE Adverse Event Report: SYNTHES GMBH DEPTH GAUGE F/LOCK-SCR MEAS-RANGE-110 F/; GAUGE,DEPTH

Catalog Number 03.010.019

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/15/2021

Event Type  malfunction  

Manufacturer Narrative

If the information is unknown, not available or does not apply, the section/field of the form is left blank.Part: 03.010.019, lot: 3792059, manufacturing site: (b)(4), release to warehouse date: 21 june 2011.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified.Visual inspection: the depth gauge f/lock-scr meas-range-110 f/ (p/n: 03.010.019, lot #: 3792059) was returned and received at us customer quality (cq).Upon visual inspection, it was observed that tip of the needle component was slightly bent.No other issues were identified.Functional test: a functional test was performed with the returned device.The device was functioning as intended and the device was also measuring as intended.Therefore, the reported condition of measuring short was not confirmed.Can the complaint be replicated with the returned device? no.Device failure/defect identified? yes.Dimensional inspection: dimensional analysis cannot be performed due to the geometry/design of the device.Document/specification review: the following documents were reviewed: current and manufactured.No design issues or discrepancies were identified.Complaint confirmed? no, the device was measuring and functioning as intended.Investigation conclusion: the complaint condition was not confirmed for the returned device.However, the tip of the needle was observed to be damaged on the device.No definitive root cause could be determined based on the provided information.The unintended forces might have contributed to the reported complaint condition.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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.

Event Description

Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2021 that the depth gauge appeared to measure 4-5mm short of what was actually being measured.The procedure was completed successfully with no delay.This report is for one (1) depth gauge.This is report 1 of 1 for (b)(4).

• Brand Name: DEPTH GAUGE F/LOCK-SCR MEAS-RANGE-110 F/
• Type of Device: GAUGE,DEPTH
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11920936
• MDR Text Key: 253747170
• Report Number: 8030965-2021-04465
• Device Sequence Number: 1
• Product Code: HTJ
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.019
• Device Lot Number: 3792059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2011
• 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