MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.5MM VA-LCKNG SCREW SLF-TPNG WITH T4 STARDRIVE RECESS 7MM; SCREW, FIXATION, BONE

Model Number 02.130.207

Device Problems Unsealed Device Packaging (1444); Use of Device Problem (1670); Appropriate Term/Code Not Available (3191)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Additional pro-code: hrs.Complainant part is not expected to be returned for manufacturer review/investigation.Occupation: synthes rep.(b)(4).Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed; 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 an unknown date, one of the screw packages did not have the variable angle (va) locking screw inside it during field inventory.The package was not altered or damaged in any way.There is no patient nor procedure involvement.This complaint involves one (1) device.This report is 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.The device has been 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.

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.H3, h6: part: 02.130.207.Lot: 4l83630.Manufacturing site: grenchen.Release to warehouse date: 25.Jun.2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the depuy synthes bag was received without content and sealed.The package includes a work instruction for the variable angle locking hand system.According to the label, the package shall include one (1) article 02.130.207, lot 4l8630.The received synthes bag is free of dirt or damages.Dimensional inspection: there were no measurements performed, however a visual inspection regarding the packaging specifications has been documented during this investigation.See details below: during the manufacturing process, the entire lot was packed and sealed in individual plastic bags in the process step 0090 ¿packaging¿.In this manual packaging process, the operator is the responsible of supplying the machine with the screw and of counting how many synthes bags there are, subsequently, the lot was inspected 100% in the step 0100 ¿inspection of documentation, product and label¿ according to the work instruction, where the operator must check each screw inside the packaging according to the specifications.In this case, the empty bag in question was not detected during the inspection in the step 0100.This may have occurred due to the additional work instruction inside the package (only required for us products), in a way that the screw is not always visible (it can remain between the label and the work instruction) and therefore, it is more difficult to detect.Thus, further investigation must be performed and adequate actions need to be taken in order to solve this issue and prevent them happening again.Noteworthy, a gdp issue has been found in the work order 16614613 where the end dates of the manufacturing steps 0090 and 0100 have been corrected.However, this information has been verified in sap, where the 21st day of june 2019 has been found as the day of completion for both tasks as corrected in the work order in question.Document/specification review: a manufacturing record evaluation was performed for the affected lot 4l83630, where no non-conformances, abnormalities nor deviations were identified which could lead to the complaint failure.In addition, the drawing of the article 02.130.207 valid at the time of manufacturing, was reviewed and no relevant design changes were identified.The initial and final lot size was 120 pieces, and were produced in june 2019.Summary: based on the investigation results, this complaint is rated as confirmed as well as valid since the returned depuy synthes bag is empty and sealed as claimed by the customer.Since a manufacturing issue has been identified, the appropriate actions have been taken to solve this issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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.Awareness date reported on follow up 1 report as august 13, 2019 but should have been september 11, 2019.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: 1.5MM VA-LCKNG SCREW SLF-TPNG WITH T4 STARDRIVE RECESS 7MM
• 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: 8984046
• MDR Text Key: 157359402
• Report Number: 2939274-2019-60434
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 10886982044617
• UDI-Public: (01)10886982044617
• Combination Product (y/n): N
• PMA/PMN Number: K141527
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 02.130.207
• Device Catalogue Number: 02.130.207
• Device Lot Number: 4L83630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2019
• Date Manufacturer Received: 10/24/2019
• Patient Sequence Number: 1