MAUDE Adverse Event Report: SYNTHES GMBH TI LOW PROFILE NEURO SCREW SELF-DRILLING 5MM; PLATE, BONE

Catalog Number 400.835

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 01/01/2020

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 there was no product inside the product packing plastic pouch.There is no hole / puncture observed on it.No further information provided.This report is for one (1) ti low profile neuro screw self-drilling 5mm.This is report 2 of 2 for complaint (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: b3: date of event is an unknown date in 2020.H6: manufacturing location: monument.Manufacturing date: december 12, 2019.Part: 400.835, ti low profile neuro screw self-drilling 5mm.Lot: 31p9277 (non-sterile).Two pieces were scrapped after being dropped.Production order traveler met all inspection acceptance criteria apart from the two pieces noted.Inspection sheet, inspect dimensional met all inspection acceptance criteria.Packaging label log (pll) was reviewed and determined to be conforming.A total of (b)(4) were printed; (b)(4) were used on product; 1 label was used on the pll and 6 labels were destroyed.Packaging bom was reviewed and determined 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.Component part(s) reviewed: part: 21015, tialnbri4.00.Lot: 15l2627.Lot summary report met all inspection acceptance criteria.Raw material receiving/put away checklist met all inspection acceptance criteria.Note: there were no supplier material certifications included in this device history record (dhr).Supplier was notated as dynamet.Product evaluation the package was not physically returned for the investigation.The investigation was requested to be based on the photographic evidence.The photo indicates that the packages have the correct lot numbers and part numbers relevant to the reported complaint.The product is not visible in photograph.The photos show both sides of the packages, however, because both sides are labeled, the interior of the package is obscured.Visually, the package appears to be sealed as is indicated by the complaint, however, because the labels obscure the interior view of the packages, it could not be determined whether the packages were, indeed, empty.Additionally, without examination it could not be confirmed whether there were any small holes in either the perforated or sealed seams of the package.The review of the product label and package photos could not confirm the complaint condition.Review of the dhr confirmed the products were manufactured at the monument jabil manufacturing site.The dhr review confirmed that all parts were indicated to have been packaged and labeled, also, all label reconciliations appear correct.Investigation summary the investigation, as based on the photographic evidence, was unable to confirm the reported complaint condition of a sealed, empty package.The results of this investigation are unconfirmed from a manufacturing perspective.Hence, the complaint is rated as n/a in the confirmed field.Should the package be physically returned, further investigation will be conducted.Product was not returned therefore no further investigation possible.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 (information or/and material), 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.

• Brand Name: TI LOW PROFILE NEURO SCREW SELF-DRILLING 5MM
• Type of Device: PLATE, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11114102
• MDR Text Key: 225108325
• Report Number: 8030965-2021-00031
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 07611819753464
• UDI-Public: (01)07611819753464
• Combination Product (y/n): N
• PMA/PMN Number: K022012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 400.835
• Device Lot Number: 31P9277
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/05/2021
• Patient Sequence Number: 1
• Treatment: CRANIAL-SCR PLUSDRIVE Ø1.6 SELF-DRILL L4