MAUDE Adverse Event Report: SYNTHES GMBH DEPTH GAUGE FOR 2.0 AND 2.4 SCREWS, LONG; GAUGE, DEPTH

Model Number 319.007

Device Problem Material Deformation (2976)

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

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a synthes 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 (b)(6) reports an event as follows: it was reported that on an unknown date that sixteen (16) depth gauges were discovered to have wear and tear.They were gummy and bent.These depth gauges have never been replaced since the sets were placed into service.This report is for one (1) depth gauge.This is report 5 of 16 for (b)(4).

• Brand Name: DEPTH GAUGE FOR 2.0 AND 2.4 SCREWS, LONG
• Type of Device: GAUGE, DEPTH
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BIO OBERDORF (CH); eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11959532
• MDR Text Key: 254951709
• Report Number: 8030965-2021-04669
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10887587039008
• UDI-Public: 10887587039008
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• 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: 05/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 319.007
• Device Catalogue Number: 319.007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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