MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 3.5MM TI CORTEX SCREW SELF-TAPPING 18MM

Catalog Number 404.818

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Type  malfunction  

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported on an unknown date that the package was received empty.There were no adverse consequences to the patient.No additional information could be provided.This complaint involves one (1) device.This report is for (1) 3.5mm ti cortex screw self-tapping 18mm.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).Additional product code: hwc.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.The investigation could not be completed, no product was received; 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.The product was returned to depuy synthes and sent to manufacturing site: jabil: grenchen for evaluation.The jabil: grenchen team conducted a visual inspection of the returned device.Visual analysis of the returned sample was performed on cortscr ø3.5 self-tap l18 ti.A manufacturing record evaluation was performed for the finished article lot and it was confirmed that above lot#96p9574 was part of the bounding of the jbl-nr-0009605.The underlying issue within the nr was defective sealing & contamination of product packages.An use-as-is disposition was executed for this lot within the corresponding jnj nr-0160760.The dimensional inspection was not performed since it was not applicable to the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for the cortscr ø3.5 self-tap l18 ti.The root cause of the complaint condition can be confirmed due to the manufacturing issue.The received condition of the cortscr ø3.5 self-tap l18 ti confirmed that the package was empty.Jabil: grenchen initiated non-conformance (nc): jbl nr-0009605 to further evaluate and determine the manufacturing error in detail that led to the complaint condition.Any further actions will be determined under jbl nr-0009605 opened at jabil: grenchen.Jnj nr-0160760 is opened to track and document jbl nr-0009605.Any further corrective/preventive actions if required will be captured under nr-0160760.Device history lot - part: 404.818, lot: 96p9574, manufacturing site: grenchen, release to warehouse date: 16 march 2021.A manufacturing record evaluation was performed for the finished article lot and it was confirmed that above lot#96p9574 was part of the bounding of the jbl-nr-0009605.The underlying issue within the nr was defective sealing & contamination of product packages.An use-as-is disposition was executed for this lot within the corresponding jnj nr-0160760.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: 3.5MM TI CORTEX SCREW SELF-TAPPING 18MM
• Type of Device: 3.5MM TI CORTEX SCREW SELF-TAPPING 18MM
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA ; SZ
• Manufacturer (Section G): WERK GRENCHEN (CH); solothurnstrasse 186; grenchen 2540 ; SZ 2540
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13080715
• MDR Text Key: 287008828
• Report Number: 8030965-2021-10440
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819076143
• UDI-Public: (01)07611819076143
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K131186
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 404.818
• Device Lot Number: 96P9574
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1