MAUDE Adverse Event Report: 1303 GOSHEN SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS; GAUGE, DEPTH

Model Number 319.006

Device Problem Break (1069)

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

Event Type  malfunction  

Event Description

It was reported that on an unknown date, during a routine incoming inspection of the loaner set at (b)(6), it was observed that the depth gauge for 2.0mm and 2.4mm screws was broken.There was no known patient or hospital involvement.This complaint involves one (1) device.This report is for one (1) depth gauge for 2.0mm and 2.4mm screws.This is report 3 of 5 for (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).Reporter is a j&j representative.The device was 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.Visual inspection: depth gauge for 2.0mm and 2.4mm screws (p/n: 319.006, lot #: a4hz293) was returned and received at us cq.Upon visual inspection, it was observed that the needle component was little bent.No other issues were identified.Dimensional inspection: complaint relevant dimensions cannot be taken due to the post-manufacturing damage.Document/specification review: the following documents were reviewed: depth gauge for 2.0/2.4mm screws: 319_006 rev p and rev c (current and manufactured).Needle: 319_006_3 rev e/ rev b (current and manufactured).No design issues or discrepancies were identified.Investigation conclusion the complaint condition was confirmed for the returned device.No definitive root cause could be determined based on the provided information.The unintended external forces might have contributed to the broken needle component leading to the reported complaint condition.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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 lot - part #: 319.006.Synthes lot #: a4hz293.Supplier lot #: n/a.Release to warehouse date: 02 nov 1998.Manufactured by: synthes brandywine.No ncrs were generated during production.Device history review - 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.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 2.0MM AND 2.4MM SCREWS
• Type of Device: GAUGE, DEPTH
• Manufacturer (Section D): 1303 GOSHEN SYNTHES USA PRODUCTS LLC; 1303 goshen parkway; 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: 12754494
• MDR Text Key: 284883374
• Report Number: 2530088-2021-00025
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982189943
• UDI-Public: (01)10886982189943
• 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
• Report Date: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 319.006
• Device Catalogue Number: 319.006
• Device Lot Number: A4HZ293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/02/1998
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1