MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM CORTEX SCREW SELF-TAPPING 26MM; PLATE,FIXATION,BONE

Model Number 204.818

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Additional product code: hwc, jds.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and 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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 (b)(6) 2019, the received envelope was empty.It was mentioned that there was nothing in the envelope and was supposed to receive five (5) items.There is no patient nor procedure involvement.This is report 3 of 4 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.Complainant part is not expected to be returned for manufacturer review/investigation.A review of the device history record.Device history lot.Manufacturing location: (b)(4).Manufacturing date: 13-sep-2019.Part number: 204.826, 3.5mm cortex screw self-tapping 26mm.Lot number: 12l9361 (non-sterile).Lot quantity: (b)(4).Inspection sheet, final inspection met all inspection acceptance criteria.Packaging label log (pll) lppf rev e, lmd rev a was reviewed and determined to be conforming.A total of (b)(4) labels were printed; (b)(4) were used on packaging, (b)(4) was used on the pll and (b)(4) 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 batch null, device history review
=
> 24-dec-2019: dhr reviewed, 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: 3.5MM CORTEX SCREW SELF-TAPPING 26MM
• 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: 9428415
• MDR Text Key: 194176157
• Report Number: 2939274-2019-62537
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982146274
• UDI-Public: (01)10886982146274
• Combination Product (y/n): N
• PMA/PMN Number: K131186
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/15/2019

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: 204.818
• Device Catalogue Number: 204.826
• Device Lot Number: 23P7105
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/15/2019
• Initial Date FDA Received: 12/06/2019
• Supplement Dates Manufacturer Received: 12/27/2019
• Supplement Dates FDA Received: 12/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1