MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 4.5MM TI CORTEX SCREW SELF-TAPPING 26MM; SCREW, FIXATION, BONE

Model Number	414.826
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional procodes: hrs, ktt.Date of implantation is unknown.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter email address is unknown.The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history records review 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 or Problem Description
Device report from synthes europe reports an event in (b)(6) as follows: on (b)(6) 2018, surgery for implant removal was performed.During the surgery, a screw broke and a piece of the screw shaft remained inside the patient¿s body.While removing the broken piece of the screw using a removal tool, part of the cortical bone was cut, and excessive bleeding occurred.The surgeon believes that the broken screw was caused by the application of excessive force.The surgery was completed with a 30-minute delay.The patient is currently visiting the hospital regularly.This report is for a 4.5mm titanium (ti) cortex screw self-tapping 26mm.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Please note, this dhr review is for sterilization procedure only: part: 414.826s; lot: l260898; manufacturing location: (b)(4); supplier: (b)(4); release to warehouse date: january 11, 2017; expiry date: january 01, 2027.Non-sterile 414.826 / l255640 was manufactured in (b)(4).Release to warehouse date: december 26, 2016.The device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.This implant was manufactured from blank 414.026.999 / lot h108319 from (b)(4).Manufacturing location: (b)(4).Manufacturing date: moved to blank storage on october 08, 2016.Part: 414.026.999, 4.6mm ti screw blank 26mm 04.5 cortex screw w/3.5 hex, lot: h108319 (non-sterile); lot quantity: (b)(4).Work order traveler met all inspection acceptance criteria.(b)(4) pieces were scrapped in cell for machine malfunction at turn point.Component part(s) reviewed: 23018, ti4c ri4.58, lot: 7813446; lot quantity: (b)(4).Product certification received from (b)(4) was reviewed and determined to be conforming.Approval certificate received from timet was reviewed and found to be conforming.Lot summary report met all inspection acceptance criteria.Raw material receiving/putaway checklist met all inspection acceptance criteria.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.Investigation selection: investigation site: (b)(4); selected flow: 5.Broken.Visual inspection: the received screw was found broken between screw head and the screw shaft.Furthermore, there are several mechanical damages visible on the surfaces.Dimensional inspection: the relevant features are heavily damaged in a manner which prevents accurate measurement of the features.Drawing/specification review: as indicated in the manufacturing documents, the damaged thread was inspected before the part left manufacturing site.The damage was clearly caused post manufacturing; by this no further review necessary.Material review: this review was conducted on semi-finished good with article 414.026.999 and lot h108319, which is a sub-component of 414.826.The manufacturing documents do show that the correct material was used and that it met all inspection acceptance criteria.Summary: our investigation has shown that the complaint condition is confirmed.Because of the damage, it is not possible to measure the relevant dimension.We are not able to determine the exact cause of this occurrence due to missing detailed clinical information.We suppose that a mechanical overload situation during use could lead to the breakage.Finally, we conclude that the cause of failure is not due to any manufacturing non-conformance's.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.
Additional 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.Date device received by manufacturer.The subject device has been received and the product evaluation is in progress.No conclusion can be drawn.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: 4.5MM TI CORTEX SCREW SELF-TAPPING 26MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7777580
• Report Number: 8030965-2018-55667
• Device Sequence Number: 13773054
• Product Code: HRS
• UDI-Device Identifier: 10886982213631
• UDI-Public: (01)10886982213631
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K112583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 414.826
• Device Catalogue Number: 414.826S
• Device Lot Number: L260898
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2018
• Initial Date Received by Manufacturer: 07/26/2018
• Supplement Date Received by Manufacturer: 08/16/2018; 08/21/2018; 09/18/2018
• Initial Report FDA Received Date: 08/13/2018
• Supplement Report FDA Received Date: 08/17/2018; 09/14/2018; 09/20/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 15 YR