MAUDE Adverse Event Report: SYNTHES GMBH 3.5MM TI LOCKING SCREW SELF-TAPPING 12MM; APPLIANCE,FIXATION,NAIL

Catalog Number 413.012

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 07/18/2021

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a j&j employee.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the packaging for the 3.5mm ti locking screw was found to be empty.There was no patient consequence.There is no further information available.This report is for one (1) 3.5mm ti locking screw self-tapping 12mm.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.H6: photo investigation: a photo investigation was completed based on the images provided.The complaint was on the empty packaging received, hence a manufacturing investigation was completed by jabil- grenchen- manufacturing site.The photo shows an empty packaging inside a bigger unknown package.Manufacturing record evaluation showed no non conformances that could have resulted in this issue.Document/specification review is irrelevant to the complaint condition of empty packaging.Conclusion: the complaint condition was confirmed based on the available information and manufacturing investigation report.During the investigation, no product design issues, or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.H6: a device history record (dhr) review was conducted: part # 413.012, lot # 4l57481, release to warehouse date: 03 may 2019 , manufacturer: grenchen , supplier: (b)(4).A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h6: part # 413.012; lot # 4l57481; release to warehouse date: may 3, 2019; manufacturer: grenchen; supplier: (b)(4).A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the lockscr ø3.5 self-tap l12 tan (p/n: 413.012 & lot #: 4l57481) was returned and received at us customer quality (cq).The complaint part was received in a non-depuy-synthes-bag.The pouch is in closed condition and the sealings of the pouch are intact at both ends.The pouch was empty and has no product inside.The empty bag was not detected in the process packaging.In this manual packaging process, the operator is responsible for supplying the machine with the screws.After finishing the packaging step, the operator checks the packaged parts to ensure that all the screws are packaged in their respective bags.This empty pouch was not detected in this step.Document/specification review: the document/dhr review was performed.Document number(s) and revision(s): unsterilized screw- finish good product: work order; inspection sheet: for mechanical production; the initial lot size was 240 pieces and the final one was 239 pieces; manufacturing date: may 3, 2019; manufacturing site: grenchen.Summary: a dhr review was performed for the affected work order.The work order started with 240 and finished with 239 pieces.The one scrap in this work order happened in the process step "etching" and the scrap code was "wrong quantity/ delivery".The parts were packed on the step " packaging".239 parts were documented as packaged and the parts were forwarded to next process step.In addition, no non-conformance, abnormalities nor deviations related to the reported complaint condition were identified.Dimensional inspection: the dimensional inspection is not required as complaint is related to the empty packaging.Complaint confirmed? yes.Investigation conclusion: the complaint condition can be confirmed for empty package.Based on the investigation result, the root cause of the complaint condition can be confirmed due to manufacturing defect happened in packaging step.A capa was initiated for this issue of empty bags in grenchen site.The product from this complaint was produced before initiation of this capa.Further investigation and escalation related to this complaint will be handled through a nonconformance.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: 3.5MM TI LOCKING SCREW SELF-TAPPING 12MM
• Type of Device: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12329317
• MDR Text Key: 266875293
• Report Number: 8030965-2021-06728
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 07611819268524
• UDI-Public: (01)07611819268524
• Combination Product (y/n): N
• PMA/PMN Number: K000684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 07/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 413.012
• Device Lot Number: 4L57481
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2021
• Date Manufacturer Received: 10/08/2021
• Patient Sequence Number: 1