MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7/3.5MM DEPTH GAUGE 0 TO 60MM; GAUGE, DEPTH

Model Number 03.133.080

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.A device history record (dhr) review was conducted: investigation summary: the complaint device (2.7/3.5mm depth gauge 0 to 60mm) was not received for investigation.A photo investigation was performed based on the photo attached in notes & attachments section of pc titled ¿image002.Jpg¿.The image was reviewed, and the complaint condition is confirmed.After review of the evidence provided, the gauge wire appears to be bent, but remains in one piece.A manufacturing record evaluation cannot be performed due to lot number being unknown.A definite assignable root cause could not be determined based on the provided information.As the device was not returned, and as-received condition could not be assessed and a dimensional inspection and document/specification review were not completed.No dhr review was completed since no lot number was supplied via photo or additional 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.Device history lot: a manufacturing record evaluation cannot be performed due to lot number being unknown.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

It was reported that, the depth gauge was found broke during packaging/shipment and not during the procedure.No patient involvement.This report is for one (1) 2.7/3.5mm depth gauge 0 to 60mm.This is report 1 of 1 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.H3, h4, h6: part #03.133.080.Synthes lot #j002243.Supplier lot #j002243.Release to warehouse date:may 26, 2021.Supplier: mack molding company.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Visual inspection: the complaint device (p/n: 03.133.080, lot: j002243) was received at us cq.A visual inspection noted that the needle of the depth gauge was bent, but remained in one piece.No other damage or defects were noted on the device.Device failure/defect identified? yes dimensional inspection: feature: shaft diameter measured dimension: conforming document/specification review: current and manufactured revisions no design or manufacturing discrepancies were noted.Complaint confirmed? no conclusion: the alleged complaint condition for the returned device is not confirmed as no components were observed to be broken.However the needle of the depth gauge was noted to be bent.No definitive root cause could be determined based on the provided information.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.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 0 TO 60MM
• Type of Device: GAUGE, DEPTH
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13061248
• MDR Text Key: 286928294
• Report Number: 2939274-2021-07196
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982269690
• UDI-Public: (01)10886982269690
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.133.080
• Device Catalogue Number: 03.133.080
• Device Lot Number: J002243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2021
• 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