MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH CORTSCR Ø3.5 SELF-TAP L30 SST; SCREW, FIXATION, BONE

Catalog Number 204.83

Device Problem Incomplete or Missing Packaging (2312)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Additional procode: jds.Reporter is a synthes employee.The device was received, the investigation is in progress, 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: it was reported that our distributor: (b)(4).Did a check on incoming items,and realized that the package contained only 4 instead of 5 cortical screws.There were no adverse consequence to a patient.This complaint involves one (1) cortical screw ø3.5 self-tap l30 sst.This is 1 of 1 for report (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.Updated initial reporter: (b)(6).Lot number updated.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.

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.A product investigation was conducted.The part was forwarded to manufacturing site for investigation with the following results: based on the investigation results, the complaint agrees with the complaint description ¿empty packaging¿ as claimed by the customer.Thus, the complaint is confirmed.However, from the manufacturing point of view, no issue was identified during the review of the manufacturing documentation.In addition, during the production of the complaint part a 100% inspection was done to check the quantity of each packed screws.The seam of the packaging was also inspected by sampling inspection and no deviation were found.Since no manufacturing deficiency has been detected, this complaint is rated as not valid.Hence, no additional actions are required.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.A device history record (dhr) review was conducted: part number: 204.830.Synthes lot number: 2l54435.Manufacturing site: grenchen.Release to warehouse date: (b)(6) 2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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: CORTSCR Ø3.5 SELF-TAP L30 SST
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9244557
• MDR Text Key: 194307158
• Report Number: 8030965-2019-69727
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 07611819076389
• UDI-Public: (01)07611819076389
• Combination Product (y/n): N
• PMA/PMN Number: K112583
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 204.83
• Device Lot Number: 2L54435
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2019
• Date Manufacturer Received: 12/18/2019
• Patient Sequence Number: 1