MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 46MM; SCREW,FIXATION,BONE

Catalog Number 04.211.046

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Additional device product codes: hrs.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is a synthes employee.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 that on an unknown date, during the reception process of a device package there were two (2) of the same type of screws found in one (1) package, when the package quantity should have been one (1).There was no patient involvement.This report involves one (1) 2.7mm ti va lckng scr slf-tpng with t8 stardrive recess 46mm.This is report 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, h6: manufacturing location: monument, manufacturing date: december 11, 2019, part: 04.211.046, 2.7mm ti va lckng scr slf-tpng with t8 stardrive recess 46mm, lot: 31p7596 (non-sterile).Seven pieces were scrapped in cell at mill shaft threads after being dropped.Forty-three pieces were scrapped in cell at turn/thread head, flute after a machine malfunction.A three piece weight variance was recorded at flow inspect/pack.Production order traveler met all inspection acceptance criteria apart from the fifty pieces noted.Inspection sheet, in process/inspect dimensional/final inspection met all inspection acceptance criteria.Packaging label log (pll) was reviewed and determined to be conforming.A total of 191 labels were printed.187 labels were used on product; 1 label was used on the pll and 3 labels were destroyed.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.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.Component part(s) reviewed: component parts were not reviewed as the reported complaint condition of ¿there are found 2 screws in the same package when there should be only 1¿ does not indicate breakage of the screw.Therefore, review of the raw materials would not be pertinent tot the reported complaint condition.Visual inspection: the investigation was conducted at the manufacturing facility, monument.The package for part number 04.211.046, lot 31p7596, was not returned for evaluation however, pictures were provided which were examined by the quality engineer.The package contains two (2) screw contents; therefore, the review supports the complainant¿s description of the complaint condition.Thus, the complaint is confirmed from a manufacturing standpoint.Relevant actions have been taken to address the issue.Manufacturing review: part number 04.211.046, lot number 31p7596 was manufactured in january 2019.Roll stock bags are pulled through the machine with power drive rollers, a label is then applied followed by a timed blast of compressed air that opens the bag.The operator then inserts product into the bag and then uses foot control to activate the sealer to seal the bag.The process then repeats itself for each piece in the production order.Per the piece pack work instruction, the following is confirmed on the first 5 and last 5 pieces: label position, bag dimensions, proper seal and components are present in the bag.At the end of the run, line clearance/label reconciliation is completed on every lot per packaging label log (pll).There were no issues with the pll reconciliation for this lot.There is no evidence to suggest the operator did not follow their process.The assignable cause is material: handling as the packaging operation is 100% manual.Investigation conclusion: the overall complaint was confirmed as the package contains two screws.The monument packaging process is specific to each production order.Therefore, packaging defects are specific to the packaging event in which they occurred.In conclusion, there is no indication of a systemic issue and the probability of occurrence is improbable for incorrect part quantity nonconformities.Relevant actions have been taken for this confirmed complaint to further investigate manufacturing root cause.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: 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 46MM
• Type of Device: SCREW,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10199918
• MDR Text Key: 196650943
• Report Number: 8030965-2020-04463
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 07611819434219
• UDI-Public: (01)07611819434219
• Combination Product (y/n): N
• PMA/PMN Number: K100776
• 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: 06/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.211.046
• Device Lot Number: 31P7596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Date Manufacturer Received: 08/17/2020
• Patient Sequence Number: 1