MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR LARGE SCREWS GAUGE, DEPTH

Model Number 319.10

Device Problem Material Twisted/Bent (2981)

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

Event Type  malfunction  

Manufacturer Narrative

Reporter is a synthes employee. Part: 319. 10. Lot: 7979726. Manufacturing site: (b)(4). Supplier: n/a. Release to warehouse date: july 24, 2012. Expiration date: n/a. A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified. Visual inspection: the complaint device, depth gauge for large screws was returned to customer quality (cq) (b)(4) for investigation. Upon visual inspection, the gauge was missing a component and the needle was slightly bent. Service and repair evaluation: the customer reported the depth gauge is missing a component. The repair technician reported the device was missing the head piece. The cause of the issue could not be determined. The reason for repair is missing component. The item is being scrapped as the s&r site did not have the components to repair. The device could not be repaired per the inspection sheet and will be forwarded to customer quality. The evaluation was confirmed. Document/specification review: based on the date of manufacture, the current and manufactured version of drawings were reviewed. Dimensional inspection: it is evident from the visual inspection that the depth gauge was missing a component, hence a dimensional inspection was not performed. Investigation conclusion: the complaint can be confirmed based on the available information. The depth gauge was missing the head piece and the needle of the gauge appeared slightly bent. 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. This report is for an unknown device/unknown lot. Part and lot number are unknown; udi number is unknown.

Event Description

It was reported that during a routine incoming inspection of the loaner set at a field stocking location (fsl) on an unknown date, it was observed that the depth gauge for large screws was missing a component. There was no patient involvement. Upon manufacturer investigation, it was determined that the needle of the device was bent. This report is for a depth gauge for large screws. This is report 1 of 1 for (b)(4).

• Brand Name: DEPTH GAUGE FOR LARGE SCREWS
• 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): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12975429
• MDR Text Key: 286861398
• Report Number: 2939274-2021-07028
• Device Sequence Number: 1
• Product Code: HTJ
• 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: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/11/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 319.10
• Device Catalogue Number: 319.10
• Device Lot Number: 7979726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown