MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 7.0MM TI MATRIX SCREW 50MM THREAD LENGTH-S; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number 04.639.750S

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/05/2020

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Pma/510k: 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, 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 on (b)(6) 2020 an l5 s1 single level fusion was performed using an orthokit loan matrix set.During the second screw insertion, the tip of a screw driver broke with the first 2 threads stripping.During insertion of the third screw the handle of another screwdriver broke clean off.A 7 x50mm screw which was being inserted was discarded as a small chard of metal was seen hanging from its head.The generated shards were removed successfully.The procedure was completed successfully with no surgical delay.Concomitant device reported: unknown screws (part # unknown, lot # unknown, quantity 3); unknown t-handle (part # unknown, lot # unknown, quantity 1).This is report 1 of 3 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, h4, h6 investigation summary picture review: narrative ( screw head with metal chip) could be confirmed from provided picture.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventive 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 history this mre review is for sterilization procedure only: part: 04.639.750s; lot: 8560564; manufacturing site: selzach; supplier: (b)(4).Release to warehouse date: 30.July 2013.Expiry date: 01.July 2023.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Non-sterile part: part number: 04.639.750; lot number: 7244752; part manufacture date: 02/05/2013; manufacturing location: brandywine; part expiration date: n/a; nonconformance noted: n/a.A review of the device history record of this lot revealed no complaint-related anomalies.The device history record shows that the 7.0mm matrix screw was processed through the normal manufacturing, inspection, and packaging operations.The product lot met all acceptance criteria at the time of release with no issues documented that would contribute to this complaint condition.The product met all manufacturing, inspection, and packaging criteria at the time of release with no issues documented that would contribute to this complaint condition.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, h4, h6- picture review: narrative (screw head with metal chip) could be confirmed from provided picture.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventive 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 history lot this mre review is for sterilization procedure only part: 04.639.750s, lot: 8560564, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: 30.July 2013, expiry date: 01.July 2023.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Non-sterile part was manufactured in monument, part:04.639.750, lot: 7244752.A dhr review was not performed for this pi.This lot was manufactured by brandywine.Please reassign this task to the correct group.Part number: 04.639.750, lot number: 7244752 , part manufacture date: 02/05/2013, manufacturing location: brandywine , part expiration date: n/a , nonconformance noted: n/a.A review of the device history record of this lot revealed no complaint-related anomalies.The device history record shows that the 7.0mm matrix screw was processed through the normal manufacturing, inspection, and packaging operations.The product lot met all acceptance criteria at the time of release with no issues documented that would contribute to this complaint condition.The product met all manufacturing, inspection, and packaging criteria at the time of release with no issues documented that would contribute to this complaint condition.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: 7.0MM TI MATRIX SCREW 50MM THREAD LENGTH-S
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10605385
• MDR Text Key: 209157452
• Report Number: 8030965-2020-07528
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07611819471160
• UDI-Public: (01)07611819471160
• 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: 09/05/2020

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 Expiration Date: 07/01/2023
• Device Catalogue Number: 04.639.750S
• Device Lot Number: 8560564
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/05/2020
• Initial Date FDA Received: 09/30/2020
• Supplement Dates Manufacturer Received: 10/08/2020; 11/04/2020
• Supplement Dates FDA Received: 10/09/2020; 11/04/2020
• Patient Sequence Number: 1
• Treatment: PEDIC-SCR-MATR 5.5 Ø7 L50 TAN; RETAIN-SLEEVE LONG F/MATRIX 5.5; RETAIN-SLEEVE STD F/MATRIX 5.5; SCRDRIVER W/T-HANDLE STD F/MATRIX 5.5; UNK - HANDLES; UNK - SCREWS; RETAIN-SLEEVE STD F/MATRIX 5.5; SCRDRIVER W/T-HANDLE STD F/MATRIX 5.5; UNK - HANDLES; UNK - SCREWS