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 Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/22/2019

Event Type  malfunction  

Manufacturer Narrative

(510k): device is not distributed in the united states but is similar to device marketed in the usa.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.

Event Description

Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2019 during a procedure to treat a tumor in the skull the screw kit (04.503.104.04s), comprised of four pieces, was used for securing a titanium plate.The surgeon was unable to insert all four screws.The surgeon did not have difficulty inserting screws of a different lot number.The surgery was completed with a ten (10) minute delay.Concomitant device: unknown plate (part # unknown, lot # unknown, quantity # 1).This report is for one (1) matneu scr 1.5 self-drill l4 tan 4u i/c.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.Corrected data: g4: awareness date reported on follow up 2 report as november 05, 2019 but should have been november 27, 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.

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.Corrected data: awareness date reported on follow up 4 report as november 05, 2019 but should have been december 17, 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.

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.Investigation selection.Investigation site: cq zuchwil.Selected flow: damaged.Visual inspection: we have received one out of four screws of article 04.503.104.04s with the lot number 2l94895 back for investigation.Microscopic examination of the complained screw shows that the thread tip is flattened/damaged.Furthermore, the recess of the screw show signs of usage and on the threads are white residues (like bone) visible.Summary: since the tip of the screw is damaged, the complaint will be rated as confirmed.However, the microscopic examination has shown the damages were caused clearly post manufacturing.It can only be assumed that too much mechanical force whilst inserting into the bone caused the damage of the tip and consequently has led to the complaint issue.As these screws are very small and quite fragile, a lot of care is required while handling.Please refer to technique guide 036.000.608.We can confirm the visible damages are not from any manufacturing non-conformity.The root cause was identified during the performed cq evaluation and therefore the in the investigation flow listed remaining investigation steps are not required.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 history lot.Part number: 04.503.104.04s.Lot number: 2l94895.Manufacturing site: bettlach.Release to warehouse date: jan 15, 2019.Expiry date: jan 01, 2029.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance 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.Investigation selection.Investigation site: cq zuchwil , selected flow: damaged.Visual inspection: we have received one out of four screws of article 04.503.104.04s with the lot number 2l94895 back for investigation.Microscopic examination of the complained screw shows that the thread tip is flattened/damaged.Furthermore, the recess of the screw show signs of usage and on the threads are white residues (like bone) visible.Summary: since the tip of the screw is damaged, the complaint will be rated as confirmed.However, the microscopic examination has shown the damages were caused clearly post manufacturing.It can only be assumed that too much mechanical force whilst inserting into the bone caused the damage of the tip and consequently has led to the complaint issue.As these screws are very small and quite fragile, a lot of care is required while handling.Please refer to technique guide 036.000.608.We can confirm the visible damages are not from any manufacturing non-conformity.The root cause was identified during the performed cq evaluation and therefore the in the investigation flow listed remaining investigation steps are not required.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 history lot part number: 04.503.104.04s, lot number: 2l94895, manufacturing site: bettlach, release to warehouse date: jan 15, 2019, expiry date: jan 01, 2029.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

Additional narrative: investigation summary: visual inspection: we have received one out of four screws of article 04.503.104.04s with the lot number 2l94895 back for investigation.The microscopic examination of the complained screw shows that the thread tip is flattened/damaged.Furthermore, the recess of the screw show signs of usage and on the threads are white residues (like bone) visible.Summary: since the tip of the screw is damaged, the complaint will be rated as confirmed.However, the microscopic examination has shown the damages were caused clearly post-manufacturing.It can only be assumed that too much mechanical force whilst inserting into the bone caused the damage of the tip and consequently has led to the complaint issue.As these screws are very small and quite fragile, a lot of care is required while handling.Please refer to the technique guide.We can confirm the visible damages are not from any manufacturing non-conformity.The root cause was identified during the performed customer quality (cq) evaluation and therefore the in the investigation flow listed remaining investigation steps are not required.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.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Corrected data: manufacturer contact details.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: 9181496
• MDR Text Key: 165963444
• Report Number: 8030965-2019-69277
• Device Sequence Number: 1
• Product Code: HWC
• 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,Followup,Followup
• Report Date: 09/25/2019

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 Catalogue Number: 04.503.104.04S
• Device Lot Number: 2L94895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2019
• Initial Date Manufacturer Received: 09/25/2019
• Initial Date FDA Received: 10/11/2019
• Supplement Dates Manufacturer Received: 11/05/2019; 11/05/2019; 12/17/2019; 11/05/2019; 12/19/2019
• Supplement Dates FDA Received: 11/25/2019; 12/16/2019; 12/17/2019; 12/18/2019; 12/19/2019
• Patient Sequence Number: 1