MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH MATNEU SCR Ø1.5 SELF-DRILL L4 TAN 4U I/C; SCREW, FIXATION, BONE

Catalog Number 04.503.104.04S

Device Problem Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/27/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Device is not distributed in the united states, but is similar to device marketed in the usa.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.A review of the device history record has been requested.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 one out of four screws (04.503.104.04s) could not be inserted straightly to cranium during an unknown surgery on (b)(6) 2019.The surgery was completed without a surgical delay and there was no harm to the patient.No further information is available.We went attention to the sales rep to comply with the prescribed reporting date.Concomitant devices reported: unknown screws matrixneuro (part# unknown, lot# unknown, quantity# 3) unknown plates: matrixneuro (part# unknown, lot# unknown, quantity# 1).This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

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.H3, h6: the device was 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: sterile part: part: 04.503.104.04s, lot: 5l02382, manufacturing site: bettlach, release to warehouse date: june 14, 2019, expiry date: june 01, 2029.Since there is no allegation against packing or sterility, a manufacturing record evaluation was not performed.Non-sterile part: synthes part: 04.503.104.20, synthes lot: h858578, supplier lot: na, released to warehouse date: march 22, 2019, manufacturing by synthes monument.No nonconformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Visual inspection: the visual inspection of the complained screw shows that the thread flanks are strongly damaged.The tip section shows also deformation and on the screw head the screw drive is badly damaged.Dimensional inspection: the relevant features are damaged in a manner which prevents accurate measurement of the features.The damages are clearly caused post manufacturing.Document/specification review: the manufacturing specifications were reviewed, and 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.Summary: due to the damages at the tip and at the screw recess, this complaint will be rated as confirmed.This failure is typically consistent with inadequate handling of the device in combination with excessive force application.This lot was manufactured in june 2019 according to the specification.We only can assume that a mechanical overloading situation, for example metallic contact, has caused the damages.As this screw is very small and quite fragile, a lot of care is required while handling.Based on the findings above and the condition of the device, we can confirm that no manufacturing related issue could be found which could have caused or contributed to the reported malfunction.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.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: MATNEU SCR Ø1.5 SELF-DRILL L4 TAN 4U I/C
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9613455
• MDR Text Key: 191577267
• Report Number: 8030965-2020-00530
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 07611819901643
• UDI-Public: (01)07611819901643
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.503.104.04S
• Device Lot Number: 5L02382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2020
• Date Manufacturer Received: 02/14/2020
• Patient Sequence Number: 1
• Treatment: UNK - PLATES; UNK - SCREWS: TRAUMA