MAUDE Adverse Event Report: SYNTHES GMBH DEPTH GAUGE FOR 2.7MM & SMALL SCREWS; GAUGE, DEPTH

Model Number 319.01

Device Problems Device-Device Incompatibility (2919); Material Deformation (2976)

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

Event Date 06/03/2023

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2023, during a saw bones orp lab, the depth gauge was bent and would not hook well.Additionally, a 2.7 cortex screw was bent.Both items were removed and will be returned to chu.All of these items were from a sawbones set from the education logistics.Additionally, one of the participants said he did not like the small battery drive drills.However, it was determined that he had no experience and needed to be in-serviced on how to properly use the drill.Once he was shown how to use the button to reverse vs oscillate, he understood.After showing the participant and testing, the drill functioned normally.Therefore , there was no allegation against the drill.There were no patient consequences/outcome.This report is for one (1) depth gauge for 2.7mm & small screws.This is report 1 of 2 for complaint (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: e3: reporter is a j&j sales representative.H3, h6: the device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h4, h6 the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the depth gauge for 2.7mm & small screws was found bent at the tip, seeing the bent condition it is reasonable to confirm the unable to assemble condition.The observed condition was consistent as an end-of-life indicator for the device.No other issues were identified.After a visual inspection per guidance provided in windchill document , it was determined that the reusable instrument device was found bent from repeated use and servicing; therefore, further investigation for the reported complaint device is not required.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed [condition] of [device] would have contributed to the complained issue.There is no indication that a design or manufacturing issue has caused the complaint condition.It was determined that the reusable instrument was worn from repeated use and servicing.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.Drawing/specifications reviewed: the following document was reviewed: windchill document ver a.2 part:319.01 synthes lot:5271354 supplier lot:n/a release to warehouse date: oct 09, 2006 manufactured by: synthes brandywine.No non conformance reports were generated during production 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 2.7MM & SMALL SCREWS
• Type of Device: GAUGE, DEPTH
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester CO 19380
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA ; 3035526892
• MDR Report Key: 17181035
• MDR Text Key: 317677021
• Report Number: 8030965-2023-07834
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982189950
• UDI-Public: (01)10886982189950
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 319.01
• Device Catalogue Number: 319.01
• Device Lot Number: 5271354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2006
• 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: DEPTH GAUGE FOR 2.7MM & SMALL SCREWS