MAUDE Adverse Event Report: SYNTHES GMBH 2.7/3.5MM DEPTH GAUGE 40 TO 100MM; GAUGE, DEPTH

Catalog Number 03.133.081

Device Problem Material Deformation (2976)

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

Event Date 12/01/2021

Event Type  malfunction  

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the depth gauges tip was found to be bent.The issue was identified when the item was received.This report involves one (1) 2.7/3.5mm depth gauge 40 to 100mm.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

If the information is unknown, not available or does not apply, the section/field of the form is left blank.Event occurred sometime in (b)(6) 2021.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Occupation: reporter is a synthes employee.Initial reporter facility name: (b)(6).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.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d9 h6: a photo investigation was performed based on the provided product single photograph.Examination of the provided image did found the distal tip of the reported device appears to be bent.No other product defects were identified.The investigation found sufficient evidence to confirm the reported event a definitive assignable root cause could not be determined based on the provided information.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.H4, h6: a device history record (dhr) review was conducted: part # 03.133.081 lot # j003944 manufacturing site: selzach release to warehouse date: 24 aug2021 supplier: synthes usa hq, inc a manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.H3, h6: the subject 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.G1.

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.Investigation summary: the complaint device was not received for investigation.A photo investigation was performed based on the provided product single photograph attached to the notes and attachments section of the pc titled "picture".Examination of the provided image did found the distal tip of the reported device appears to be bent.No other product defects were identified.The investigation found sufficient evidence to confirm the reported event.A definitive assignable root cause could not be determined based on the provided information.As the device was not returned, an as-received condition could not be assessed.And a dimensional inspection document/specification review were not completed the product was returned to us cq for evaluation.The us cq team conducted a visual inspection of the returned device.Visual analysis of the returned depth gauge 2.7/3.5 40-100 determined that the distal end of the depth gauge shaft pin was bent.No other issues were identified with the returned device.No new additional information can be added after reviewing the image under pc attachment "picture.Jpg".The dimensional inspection was not performed due to the post manufacturing damage.The observed condition of the depth gauge 2.7/3.5 40-100 was consistent with a random component failure that may have been caused by exposure to unintended forces during transportation/shipment.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 gauge 2.7/3.5 40-100 as it was observed to be in the bent condition.While no definitive root cause could be determined from the available information, it is probable that the depth gauge 2.7/3.5 40-100 was bent due to exposure to unintended forces during transportation/shipment.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.Drawing/specifications reviewed- the following drawings reflecting the current and manufactured revisions were reviewed.Device history lot - part # 03.133.081, lot # j003944, manufacturing site: selzach, release to warehouse date: 24 aug2021, supplier: (b)(4).A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.,part # 03.133.081, lot # j003944, manufacturing site: selzach, release to warehouse date: 24 aug2021, supplier: (b)(4).A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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: 2.7/3.5MM DEPTH GAUGE 40 TO 100MM
• Type of Device: GAUGE, DEPTH
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach CO 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13114387
• MDR Text Key: 289354064
• Report Number: 8030965-2021-10548
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 07612334122049
• UDI-Public: (01)07612334122049
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.133.081
• Device Lot Number: J003944
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/16/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/24/2021
• 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