MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.0MM TI CRTX SCREW SLF-TPNG W/PLUSDRIVE(TM) RECESS 6MM; SCREW FIXATION INTRAOSSEOUS

Catalog Number 401.043

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Additional pro-code: jey.Occupation: synthes sales rep.A review of the device history record has been requested.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.The investigation could not be completed; 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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: t was reported on (b)(6) 2019, during incoming goods checking, a titanium self-tapping cortex screw was noted to be missing in the sealed packaging.There was no patient involvement.This complaint involves one (1) device.This report is 1 of 1 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.H3, h4, h6: a review of the device history record device history lot, manufacturing location: monument, manufacturing date: 26-jul-2018, part number: 401.043e, 2.0mm ti crtx screw slf-tpng w/plusdrive ¿ recess 6mm, lot number: h693487 (non-sterile), lot quantity: 99.Work order traveler met all inspection acceptance criteria.Inspection sheet, inspect dimensional/final inspection, ns034687 rev u met all inspection acceptance criteria.Packaging label log (pll) lmd rev ab was reviewed and determined to be conforming.One hundred labels were printed; ninety-nine were used on product and one was used on the pll.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Device history batch null, device history review 13-may -2019 this lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.H3, h6: investigation summary complaint description.It was reported that on (b)(6) 2019 during incoming goods checking, a titanium self-tapping cortex screw was noted to be missing in the sealed packaging.There was no patient involvement.The device was received at us customer quality (cq) and forwarded to manufacturing (monument); the following manufacturing investigation was provided to us cq (reference product investigation action a-2642375 and attachment (b)(4) investigation memo -signed).Investigation flow: labeling/packaging.Visual inspection the package was returned for evaluation and examined.There was no screw inside the package.The package was sealed and no holes were visible in the package.The package had the correct lot and part number.Received empty bag was measured against the drawing and it meets specification.It can be concluded that the package was sealed without a device within.Manufacturing record evaluation a review of the manufacturing history for this part does not show any indication that an empty package existed in the lot, however the cause of the complaint condition would be determined as operator error in which the operator did not place a product in the package during the processing of this lot.Conclusion the complaint was confirmed with investigation.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.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: 2.0MM TI CRTX SCREW SLF-TPNG W/PLUSDRIVE(TM) RECESS 6MM
• Type of Device: SCREW FIXATION INTRAOSSEOUS
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8613539
• MDR Text Key: 145388974
• Report Number: 8030965-2019-63990
• Device Sequence Number: 1
• Product Code: DZL
• UDI-Device Identifier: 07611819772403
• UDI-Public: (01)07611819772403
• Combination Product (y/n): N
• PMA/PMN Number: K102656
• 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: 04/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 401.043
• Device Lot Number: H693487
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2019
• Date Manufacturer Received: 07/12/2019
• Patient Sequence Number: 1