MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR LOCKING SCREWS TO 100MM FOR IM NAILS GAUGE,DEPTH

Model Number 03.010.072

Device Problems Break (1069); Component Missing (2306); Material Twisted/Bent (2981)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Part: 03. 010. 072. Lot: 1774697. Manufacturing site: (b)(4). Release to warehouse date: november 15, 2007. A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified. The depth gauge for locking screws to 100mm for im nails (p/n: 03. 010. 072, lot number: 1774697) was received at us customer quality (cq). Visual inspection of the complaint device showed that the needle component was slightly bent near the proximal end, ball and spring components on slider assembly were missing. Device failure/defect identified? yes. Dimensional inspection: drawing. Specified dimensions: needle outer diameter at proximal end
=
2. 5 +0/-0. 1 mm. Measured dimensions: needle outer diameter near bent location
=
2. 44mm, conforming. Device used ¿ caliper ca802. Dimensional analysis on the hole for the missing ball and compression spring components could not be performed due to deformation from the staking process that happens during the final assembly. Document/specification review: current and manufactured were reviewed. Current and manufactured were also reviewed. No design issues or discrepancies were identified. Complaint confirmed? yes. Investigation conclusion: this complaint was confirmed as the device needle/hook component was bent, ball and spring components were missing. No definitive root cause could be determined based on the provided information. 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 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 on an unknown date, the depth gauge was found broken during reverse logistics audit of returned device at millstone. There was no patient involvement. This report involves one (1) depth gauge for locking screws to 100mm for im nails. This is report 1 of 1 for (b)(4).

• Brand Name: DEPTH GAUGE FOR LOCKING SCREWS TO 100MM FOR IM NAILS
• 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): SYNTHES HAEGENDORF GMBH-CN; im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 9967259
• MDR Text Key: 187883080
• Report Number: 2939274-2020-01861
• 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: other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/23/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/16/2020
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 03.010.072
• Device Catalogue Number: 03.010.072
• Device Lot Number: 1774697
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown