MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 18MM; PLATE,FIXATION,BONE

Model Number 02.211.018

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Additional procode: hwc.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j 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

It was reported that on an unknown date, the reporter placed an order and when received at the hospital to restock the tray, there was no product in the package of the variable angle (va) locking screw, though the package was fully sealed.There was no patient involvement.This report is for one (1) 2.7mm va lckng screw slf-tpng with t8 stardrive recess 18mm.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Investigation summary: customer quality photo investigation: the complaint device was not received for investigation.The following investigation is based on the image(s) provided.The image(s) was reviewed, and the complaint condition could be confirmed as packaging contained no devices.Since the device was not returned, a dimensional inspection and a functional test were not able to be performed.Manufacturing investigation conducted by monument: visual inspection: as received: the package for part number 02.211.018, lot 58p3781 was not returned for evaluation however pictures were provided which were examined by the quality engineer.The package does not contain a screw therefore, the review supports the complainant¿s description of the complaint condition.Therefore, this complaint is confirmed from a manufacturing standpoint.(b)(4) has been initiated for this confirmed complaint to further investigate manufacturing root cause.Manufacturing record evaluation: manufacturing review: part number 02.211.018, lot number 58p3781 was manufactured in june 2020.The parts were packaged on june 3, 2020 on sharp packaging machine (b)(4).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 (b)(4)|rev.2, 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 f-s252 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.Nc review: a 1-year review was completed for related nonconformities for part family (02.211.008 ¿ 02.211.013 & 02.211.014 ¿ 02.211.060).The review found 2 nc¿s: (b)(4) for part number 0.211.018 for complaint (b)(4) (this complaint); (b)(4) for part number 02.211.046 for scar (b)(4).Product complaint review: the complaint data was reviewed for a 2-year period from sep 3, 2018 to sep 3, 2020 for valid complaints for packaging: incorrect quantity for all 2.7 mm ss variable angle screws (02.211.008 ¿ 02.211.013 & 02.211.014 ¿ 02.211.060).The review found 4 complaints: (b)(4) for part number 02.211.018 (this complaint); (b)(4) for part number 02.211.012; (b)(4) for part number 02.211.012; (b)(4) for part number 02.211.016.Process risk: per (b)(4) - rev.A, line 1610: hazard: wrong parts count; manufacturing failure: incorrect package content; incorrect part quantity, incorrect or missing insert; worst case harm: user dissatisfaction; worse case severity of harm =(b)(4) and the probability of occurrence=(b)(4); risk level: accept.The sales data for 2 years (06/2018 thru 06/2020) for 2.7 mm ss variable angle screws (02.211.008 ¿ 02.211.113 & 02.210.014 ¿ 0.211.060) is (b)(4) units.The occurrence rating for incorrect part quantity for 2 years for = (b)(4).Per (b)(4) rev: 14, the probability of occurrence = (b)(4) or improbable.The occurrence rating is in alignment with the risk document probability of occurrence harm = (b)(4).Conclusion: 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.During the investigation no product design issues or discrepancies were observed (based on the images) 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 history lot: manufacturing location: monument.Manufacturing date: june 3, 2020.Part number: 02.211.018, 2.7mm va lckng screw slf-tpng with t8 stardrive recess 18mm lot number: 58p3781.Production order traveler met all inspection acceptance criteria.There was a (b)(4)piece count variance reported at op # (b)(4), sputter coating.Inspection sheet, in-process / inspect dimensional / final inspection, (b)(4) rev j met all inspection acceptance criteria.Packaging label log (pll) lppf rev c, lmd rev a was reviewed and determined to be conforming.A total of (b)(4) labels were printed; (b)(4) labels were placed on product; 1 label was used on the pll and 2 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 was no product in the package though the package was fully sealed¿ does not indicate breakage of the screw.Therefore, review of the raw materials would not be pertinent to the reported complaint condition.Device history review: jul 22, 2020: dhr reviewed by: mschoenfeld.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 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 VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 18MM
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10367853
• MDR Text Key: 201918003
• Report Number: 2939274-2020-03374
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982053602
• UDI-Public: (01)10886982053602
• Combination Product (y/n): N
• PMA/PMN Number: K103243
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/14/2020

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
• Device Operator: Health Professional
• Device Model Number: 02.211.018
• Device Catalogue Number: 02.211.018
• Device Lot Number: 58P3781
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/14/2020
• Initial Date FDA Received: 08/05/2020
• Supplement Dates Manufacturer Received: 09/15/2020
• Supplement Dates FDA Received: 09/17/2020
• Patient Sequence Number: 1