MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 4.5MM CORTEX SCREW SELF-TAPPING 38MM; SCREW, FIXATION, BONE

Model Number	214.838
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional patient identifier: (b)(6).Patient age, date of birth, and weight not available for reporting.Additional product code: ktt.Device malfunctioned intra-operatively and was not implanted / explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Facility address and telephone not available for reporting.The investigation could not be completed; no conclusion could be drawn, as no product was received.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: it was reported during a right hip surgical procedure on (b)(6) 2018, while placing two (2) separate cortical screws, the screw heads broke, leaving the broken screw in the patient.Surgery was completed with no reported delay.This report is for one (1) 4.5mm cortex screw.This is report 1 of 2 for (b)(4).
Additional Manufacturer Narrative
Date returned to manufacturer.Subject device has been received and is currently in the evaluation process.Corrected data: device malfunctioned intra-operatively and was not implanted / explanted.Physical manufacture location, date of manufacture.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.Dhr review was completed.Part: 214.838 lot: l659469 manufacturing site: mezzovico release to warehouse date: 20.Nov.2017 no ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The review has shown that the screw was made out of blank 214.038.999 with lot h440056.Therefore an additional dhr review from monument is needed: blank manufacturing location: monument manufacturing date: moved to blank storage on 22-sep-2017 part #: 214.038.999, lot#: h440056 (non-sterile) - 4.6mm screw blank 38mm 04.5 cortex screw w/3.5 hex.Quantity: 960.Components part 13008 lot h210706 meet specification.Raw material was provided by carpenter technology corporation.Certificate of tests provided by carpenter meet specification.Raw material receiving/put away checklist meets specification.No ncrs were generated during production.Review of the device history record(s) showed that there were no other issues during the manufacture of the product that would contribute to this complaint condition.Customer quality conducted an investigation of the returned device.This complaint is confirmed.The returned cortical screw is broken as reported.The oblique break occurred at the second most proximal threadform and only the screw head with a portion of 2 shaft threadforms was returned.The material surface at the fracture site appears homogeneous when viewed under 5x magnification.It was reported that the distal threaded shaft section of the screw remains in the patient.Whether this complaint can be replicated at customer quality (cq) via functional test is not applicable for this complaint condition as the returned device is already broken.No new malfunctions were identified as a result of the investigation.The returned screw was manufactured in november 2017.No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The review has shown that the screw was made out of blank 214.038.999 with lot h440056.Therefore an additional dhr review from monument is needed: blank manufacturing location: monument manufacturing date: moved to blank storage on 22-sep-2017 part #: 214.038.999, lot#: h440056 (non-sterile) - 4.6mm screw blank 38mm 04.5 cortex screw w/3.5 hex.Quantity: 960.Components part 13008 lot h210706 meet specification.Raw material was provided by carpenter technology corporation.Certificate of tests provided by carpenter meet specification.Raw material receiving/put away checklist meets specification.No ncrs were generated during production.Review of the device history record(s) showed that there were no other issues during the manufacture of the product that would contribute to this complaint condition.The material and relevant material properties were determined to be conforming at the time of manufacture based on review of the dhr and therefore further material testing was determined to not be required.Tabulated product drawing (made to & current revision) for the family of 4.5mm self-tapping cortex screws was reviewed during this investigation.The 4.5mm cortex screws are implants routinely used in the 4.5mm va-lcp curved condylar plate system.No product design issues or discrepancies were observed.An accurate relevant dimensional inspection could not be performed on the returned part due to the oblique fracture angle and not returned threaded shaft section.No product design issues or manufacturing discrepancies were observed during this investigation.A definitive root cause for this complaint could not be determined based on the reported information.However it is most likely due to over-torquing the device or inserting the screw into hard bone or not predrilling prior to attempted insertion.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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 CORTEX SCREW SELF-TAPPING 38MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7393686
• Report Number: 8030965-2018-52737
• Device Sequence Number: 1421776
• Product Code: HWC
• UDI-Device Identifier: 10886982154682
• UDI-Public: (01)10886982154682(10)L659469
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• PMA/510(K) Number: K112583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/07/2018

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
• Operator of Device: Health Professional
• Device Model Number: 214.838
• Device Catalogue Number: 214.838
• Device Lot Number: L659469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Initial Date Received by Manufacturer: 03/07/2018
• Supplement Date Received by Manufacturer: 04/11/2018; 05/18/2018
• Initial Report FDA Received Date: 04/03/2018
• Supplement Report FDA Received Date: 05/02/2018; 05/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1