MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.0MM CRTX SCR S/TAP 34MM SCREW, FIXATION, BONE

Model Number 206.434

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Patient Involvement (2645)

Event Type  Malfunction  

Manufacturer Narrative

There was no known reported patient involvement associated with the complained event. A device history record (dhr) review was conducted. Manufacturing location: (b)(4); release to warehouse date: 23-feb-2018. Part number: 206. 434 4. 0mm cortex screw self-tapping 34mm lot number: h573984 lot quantity: 239 work order traveler met all inspection acceptance criteria. Inspection sheet, final inspection met all inspection acceptance criteria. Packaging label logs lppf, lmd/lpf rev b were reviewed and found to be conforming. One log was for a quantity of 236 labels used on parts, 1 label affixed to the log and 4 labels destroyed (poor print quality) for a total of 241 labels printed. The second label log was for 3 labels used on parts, 1 label affixed to the log and zero labels destroyed for a total of 4 labels printed. This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the production of this lot that would contribute to this complaint condition. A product investigation was conducted. The empty package was received at us cq and then sent to monument for a manufacturing evaluation. The following investigation summary was completed by manufacturing in (b)(6). Investigation summary: as received: package was returned for evaluation and examined. There is no screw inside package. Package was sealed, and no holes were visible in package. Package has correct lot and part number. Received empty bag was measured against the relevant drawing in which it meets specification for bag. The product review supports the complainant¿s description of the complaint condition therefore this is a confirmed compliant. A review of the manufacturing history for this part does not show any indication that an empty package existed in the lot, however the cause of the complaint condition would be determined as operator error in which the operator did not place a product in the package during the processing of this lot. This lot has been sold in its entirety therefore no inventory exists in monument to review for additional empty packages. This is a confirmed complaint, non-conformance (nc) has been initiated. According to the dhr review this lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the production of this lot that 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.

Event Description

It was reported that on an unknown date, a sealed, empty cortex screw package was received. There was no patient involvement. This report is for one (1) 4. 0mm cortex screw. This is report 1 of 1 for complaint (b)(4).

• Brand Name: 4.0MM CRTX SCR S/TAP 34MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7943277
• MDR Text Key: 123383747
• Report Number: 2939274-2018-54222
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: K112583
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,HEALTH
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Type of Report: Initial
• Report Date: 06/01/2018

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 10/08/2018
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: 206.434
• Device Catalogue Number: 206.434
• Device LOT Number: H573984
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 08/01/2018
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/28/2018
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 02/23/2018
• Is The Device Single Use?: Yes

Is this a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Unkown