MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.0MM CORTEX SCREW SELF-TAPPING 16MM; SCREW,FIXATION,BONE

Model Number 201.816

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Additional product code dzl, hrs.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.

Event Description

It was reported that on (b)(6) 2018, upon taking the restock from the sims cabinet in the account to restock the sets, and an unopened baggie was pulled out from the drawer.It was noted that it did not contain the right cortex screw or the sterilization instructions for an implant.The cortex screw was purchased by the hospital and was shipped with an empty package.There was no procedure or patient involvement.This report is for one (1) 2.0mm cortex screw self-tapping 16mm.This is report 1 of 1 for (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.A device history record (dhr) review was conducted: manufacturing location: monument, manufacturing date: 23-mar-2018, part number: 201.816, 2.0mm cortex screw self-tapping 16mm, lot number: h600625 (non-sterile), lot quantity: (b)(4).Work order traveler met all inspection acceptance criteria.Inspection sheet, inspect dimensional / final inspection, met all inspection acceptance criteria.Packaging label log (pll) lppf rev b was reviewed and determined to be conforming.Packaging bom was reviewed and found to be conforming with no deviations to normal packaging identified.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A product investigation was conducted.Investigation flow: labeling & packaging.Visual inspection: as received: package was returned for evaluation and examined.The package returned, in fact, does not contain a product.It also does not contain a product ifu because there is not one required by the bill of material for this product number (201.816).Although the seals and edges of the packaging are intact, there is a small hole in the perforation from which the product appears to have been removed.Investigation summary the product review does not support the complainant¿s description of the complaint condition therefore this is an unconfirmed compliant.A review of the manufacturing history for this lot (h600625) does not show any indication of a count discrepancy in which a part would have been missing from the package/lot.Additionally, the packaging has anomalies in which there is a hole in the perforation where the product appears to have been removed.With this evidence it could not be determined that depuy synthes monument manufacturing was responsible for the missing product.From a manufacturing investigation standpoint, this complaint is unconfirmed the received condition does agree with the complaint description of an empty package and a missing ifu, though no manufacturing or packaging issue was identified as the package was opened and no ifu is required per the bill of materials.During this investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition.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: 2.0MM CORTEX SCREW SELF-TAPPING 16MM
• Type of Device: SCREW,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8161082
• MDR Text Key: 130331458
• Report Number: 2939274-2018-55390
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 10886982142986
• UDI-Public: (01)10886982142986
• Combination Product (y/n): N
• PMA/PMN Number: K964261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201.816
• Device Catalogue Number: 201.816
• Device Lot Number: H600625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Date Manufacturer Received: 01/11/2019
• Patient Sequence Number: 1