MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.4MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 12MM; PLATE, BONE

Catalog Number 04.503.642.01S

Device Problem Device-Device Incompatibility (2919)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/15/2020

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2020 during an unknown procedure the screw was placed in the screw holder.When the surgeon tried to pick up the screw, it stuck in holder and did not come out.The procedure was completed without surgical delay.This report is for one (1) 2.4mm ti matrixmandible locking screw slf-tpng 12mm.This is report 1 of 2 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H3: a product investigation was completed.The screw was received in an assembled condition at the screw holder.The sterile packaging (inner/outer packaging) is missing.And is not returned for an further evaluation.No other visual damage could be observed.The function test was conducted with the result, that the first turn by unscrewing was slightly hard.After this, the screw come out as per designed intended.The complaint is confirmed, as the first turn by unscrewing was slightly hard.But after this, the screw come out as per designed intended.The root cause for this occurrence "it stuck in holder" cannot be clearly determined.It is likely, that there was a technical complication, during preparation/pick up of this screw.A handling failure (screw pick in the wrong direction) or use a damaged screwdriver shaft, which lead to the complaint condition could not be verified anymore.As the lot number is unknown, we are not able to research the device history record, manufacturing documents and packaging criteria at the time of release.Especially, the packaging criteria of the screw in the screw holder in question could not be checked of the specification.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.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: 2.4MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 12MM
• Type of Device: PLATE, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10817256
• MDR Text Key: 218993183
• Report Number: 8030965-2020-08803
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• PMA/PMN Number: K063790
• 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: 10/16/2020

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: 04.503.642.01S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Initial Date Manufacturer Received: 10/16/2020
• Initial Date FDA Received: 11/10/2020
• Supplement Dates Manufacturer Received: 01/05/2021
• Supplement Dates FDA Received: 01/08/2021
• Patient Sequence Number: 1
• Treatment: UNK - INSERTION INSTRUMENTS: TRAUMA