MAUDE Adverse Event Report: SYNTHES GMBH TI LOW PROFILE NEURO SCR SELF-DRL 4-5PK; PLATE, BONE

Model Number 400.834

Device Problem Device-Device Incompatibility (2919)

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

Event Date 05/30/2022

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).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.Complainant part is expected to be returned for manufacturer review/ investigation but has yet to be received.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.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the photo.Visual analysis of the photo revealed that there was no damage or defects with the ti low profile neuro scr self-drl 4-5pk.A functional test to assess the unable to assemble condition was not conducted since the device was not returned.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/ specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the ti low profile neuro scr self-drl 4-5pk was found to have no damage or defects.No definitive root cause could be determined.There was no indication that a design or manufacturing issue contributed to the complaint.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 history lot: manufacturing location: (b)(4), manufacturing date: 05-may-2021, part number: 400.834, ti low profile neuro screw self-drilling 4mm, lot number: 149p092 (non-sterile), lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Inspection sheet, inspect dimensional, ns035169 rev b met all inspection acceptance criteria.Packaging label log (pll) lmd rev ac was reviewed and determined to be conforming.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 number: 21015, tialnbri4.00, lot number: 61p6706, lot quantity: (b)(4).Inspection instruction met all inspection acceptance criteria.Certified test report supplied by (b)(4) company dated 05-jun-2020 was reviewed and determined to be conforming.Lot summary report dated 09-jul-2020 met all inspection acceptance criteria.Raw material receiving/putaway checklist met all inspection acceptance criteria.Device history review 16-jun-2022: 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.

Event Description

Device report from synthes reports an event in china as follows: it was reported that the device could not self drill.It was reported that during the surgery, when insert the screw, noted the self drilling screws could not drill (as the photo shows).Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be provided.This complaint involves one(1) device ti low profile neuro scr self-drl 4-5pk.This is report 1 of 1 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: h4: the device manufacture date was reported as unknown on the initial report; and has been updated accordingly.Investigation summary :the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the threads of the ti low profile neuro scr self-drl 4-5pk has worn also the distal tip has worn too.The device present white smears along the shaft (please review a019 ¿ 20220720_104900 in notes & attachments).The device returned is a representative sample and not the complaint device but shows signs of attempted use.No other problems were reported.A dimensional inspection for the ti low profile neuro scr self-drl 4-5pk was unable to be performed due to post manufacturing damage.A functional test was unable to be performed due to the mating devices / tools were not returned.The complaint condition was not able to be replicated.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the ti low profile neuro scr self-drl 4-5pk would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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 history review: part number: 400.834, ti low profile neuro screw self-drilling 4mm, lot number: 149p092 (non-sterile): 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.H10: correction narrative: g1: the manufacturing site name has been updated to reflect the correct information.

• Brand Name: TI LOW PROFILE NEURO SCR SELF-DRL 4-5PK
• Type of Device: PLATE, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14840181
• MDR Text Key: 303243840
• Report Number: 8030965-2022-04382
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 20887587045402
• UDI-Public: (01)20887587045402
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K022012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 400.834
• Device Catalogue Number: 400.834
• Device Lot Number: 149P092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/01/2022
• Initial Date FDA Received: 06/28/2022
• Supplement Dates Manufacturer Received: 08/02/2022
• Supplement Dates FDA Received: 08/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2021
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1