MAUDE Adverse Event Report: SYNTHES GMBH 2.0MM TI LCKNG SCREW SLF-DRLG W/PLUSDRIVE(TM) RECESS 6MM; PLATE, BONE

Catalog Number 401.956

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Occupation: 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 incoming goods check, the distributor found that the package was empty.There was no patient involvement.This report involves one (1) 2.0mm ti lckng screw slf-drlg w/plusdrive(tm) recess 6mm.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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.B5 update event description of product complaint: empty packing.It was reported that our distributor did incoming goods checking, noted the packing was empty, (did not open the packing).There were no adverse consequences to the patient.No additional information could be provided.D10: concomitant device reported.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

Update: empty packing.It was reported that our distributor did incoming goods checking, noted the packing was empty as the photos show (did not open the packing).There were no adverse consequences to the patient.No additional information could be provided.

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.H10 additional narrative: updated data: h6.Investigation summary: investigation.The package for part number 401.956, lot 16l9090 was not returned for evaluation however pictures were provided and they 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.See photos below.Product disposition.The review of the pictures supports the complainant¿s description of the complaint condition.Therefore, this complaint is confirmed from a manufacturing standpoint.Manufacturing review: part number 401.956 (2.0mm ti lckng screw slf-drlg w/plusdrive ¿ recess), lot 16l9090 (non-sterile) was manufactured in the monument, co facility.Manufacturing date is: oct 22, 2019.Production order traveler met all inspection acceptance criteria.Inspection sheet, final inspection, ns056048 rev e met all inspection acceptance criteria.Parts were vision counted at op #40, flow inspect/pack, and the count was confirmed at 89 pieces.2 parts are documented as scrap at this step, for ¿weight count-weight variance¿ (scrap code: wv).Packaging label log (pll) lmd rev ab was reviewed and determined to be conforming.A total of 90 labels were printed; 89 were used on product; 1 label was used on the pll and 0 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.Lot 16l9090 was packaged on 10/19/2019, on machine 7003, per process sheet: ps073847 rev.B.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 103575639|rev.2, the following is confirmed on the first 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 rev.11, packaging label log (pll).There were no issues with the pll reconciliation for this lot: pll dated 10/19/2019 documents that 89 labels were placed on product and 89 good parts are documented at the packaging operation, step 0040 on router.There is no evidence to suggest the operators did not follow their process.This process is entirely manual.Process risk: per risk document prm0757 rev.H (line 1111), "hazard: package empty, potentially noticed intraoperatively" has a worst case harm of "user dissatisfaction" - with a severity of harm of 1 and a probability of occurrence of harm 1.Risk level = accept.The empty package was found after expected point of detection but does not impact a critical defect, therefore risk is designated as low.Summary: the review of the pictures supports the complainant¿s description of the complaint condition.Therefore, this complaint is confirmed from a manufacturing standpoint.Per the product complaint description there was no patient involvement.Device history lot.Manufacturing location: monument.Manufacturing date: oct 22, 2019.Part number: 401.956, 2.0mm ti lckng screw slf-drlg w/plusdrive ¿ recess 6mm.Lot number: 16l9090 (non-sterile).Production order traveler met all inspection acceptance criteria.Inspection sheet, final inspection, ns056048 rev e met all inspection acceptance criteria.Parts were vision counted at op #40, flow inspect/pack, and the count was confirmed at 89 pieces.Packaging label log (pll) lmd rev ab was reviewed and determined to be conforming.A total of 90 labels were printed; 89 were used on product; 1 label was used on the pll and 0 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.Device history review 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: 2.0MM TI LCKNG SCREW SLF-DRLG W/PLUSDRIVE(TM) RECESS 6MM
• Type of Device: PLATE, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11207561
• MDR Text Key: 227960796
• Report Number: 8030965-2021-00485
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• PMA/PMN Number: K974555
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 401.956
• Device Lot Number: 16L9090
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/11/2021
• Patient Sequence Number: 1
• Treatment: LOCK-SCR PLUSDRIVE Ø2