MAUDE Adverse Event Report: SYNTHES GMBH DEPTH PROBE FOR MULTILOC HUM NLING SYS; SURGICAL DEPTH GAUGE, REUSABLE

Model Number 03.019.029

Device Problem Break (1069)

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

Event Date 05/22/2022

Event Type  malfunction  

Event Description

Device report from depuy synthes reports an event in canada as follows: it was reported by the sales rep in canada that during a routine trauma case on (b)(6) 2022, it was observed that the depth probe device broke into two pieces.According to the report, the surgeon was able to read his measurements from the calibrated drill; and therefore, the surgery was not delayed and proceeded as planned.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.This report is for one (1) device.

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.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.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.

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.H10 additional narrative: investigation summary: the photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the photo.Visual analysis of the photo revealed that the depth probe for multiloc hum nling sys was found the device broken in two.No other defect was found in the photo provided.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for the depth probe for multiloc hum nling sys.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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 history review: a manufacturing record evaluation was performed for the part #: 03.019.029, us lot #: l625265; and no non-conformances were identified.

• Brand Name: DEPTH PROBE FOR MULTILOC HUM NLING SYS
• Type of Device: SURGICAL DEPTH GAUGE, REUSABLE
• 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: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14771414
• MDR Text Key: 302926825
• Report Number: 8030965-2022-04199
• Device Sequence Number: 1
• Product Code: HXB
• UDI-Device Identifier: 10886982069696
• UDI-Public: 10886982069696
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/21/2022

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 Model Number: 03.019.029
• Device Catalogue Number: 03.019.029
• Device Lot Number: L625265
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/25/2022
• Initial Date FDA Received: 06/22/2022
• Supplement Dates Manufacturer Received: 07/11/2022
• Supplement Dates FDA Received: 08/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2017
• 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