MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH EXTRACTION SCREW/M8 FOR SUPRAPATELLAR; EXTRACTOR

Catalog Number	03.010.446
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is expected to be returned for manufacturer review/investigation, but has not been received yet.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Additionally, 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: it was reported that on (b)(6) 2018, patient underwent an expert tibial nail removal surgery due to pain.During surgery, one (1) extraction screw for tibial nail could not be connected to the nail.Another one (1) extraction screw for suprapatellar could be attached to the nail but it came off when the surgeon used a slide hammer.The surgeon tried several times and ended with the same result.The surgery was finished by removing only the locking screw and the nail was left in the patient's body.The surgeon stated it was not a problem due to the patient reported pain where the screw head was located.The procedure was successfully completed with a surgical delay of thirty (30) minutes.This (b)(4) captures intra-operative event occurred on (b)(6) 2018.(b)(4) captures post-operative pain that required revision surgery.This report is for one (1) extraction screw for suprapatellar.This is report 2 of 3 for (b)(4).
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.The device has been 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.
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.A device history record (dhr) review was conducted: part: 03.010.446 lot: f-20826 manufacturing site: selzach supplier: sphinx werkzeuge ag release to warehouse date: 11.Oct.2016 the device history record shows this lot of 126 pieces 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.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.A product investigation was conducted.Visual inspection: visual inspection of the complaint device identifies that the connecting thread is badly damaged.The thread is plastically deformed post-manufacturing, we can confirm that the visible damages are from use of the instrument.Such damages can occur if the connection between the extraction screw and the nail is not fitting properly when applying hard hammer blows.Furthermore the instrument has scratches, dents and small deformation all over the surface which also indicates hard use.Drawing/specification review: drawings and revisions are in accordance to dhr of production lot f-20826.All relevant features are defined on the used drawing revisions of dhr of production lot f-20826.Dimensional inspection: because of the damage (thread), the complaint relevant dimensions cannot be checked for dimensional accuracy.Summary: no product related issue could be identified.This instrument left manufacturing site in faultless condition after completed final inspection with no findings.Device use was identified as root cause for the reported problem.No product fault could be identified.To prevent such problems, it is necessary worn or damaged instruments to replace and/or to operate according to the relevant technique guide.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: EXTRACTION SCREW/M8 FOR SUPRAPATELLAR
• Common Device Name: EXTRACTOR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7943426
• Report Number: 8030965-2018-57071
• Device Sequence Number: 1665148
• Product Code: HWB
• UDI-Device Identifier: 07611819447950
• UDI-Public: (01)07611819447950
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/18/2018

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 Catalogue Number: 03.010.446
• Device Lot Number: F-20826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2018
• Initial Date Received by Manufacturer: 09/18/2018
• Supplement Date Received by Manufacturer: 10/08/2018; 11/13/2018
• Initial Report FDA Received Date: 10/08/2018
• Supplement Report FDA Received Date: 10/24/2018; 11/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1