MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SPEED COMPRESSION IMPLANT KIT 20X20X20MM; BONE STAPLE

Model Number	SE-2020
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.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 or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that the item was opened within theater but the staple was dislodged from the handle.Another staple was used to complete the procedure.The item was disposed of as per hospital policy.No time added to the procedure.Patient details unavailable.Concomitant device reported: unknown handle (part # unknown, lot # unknown, quantity unknown).This report is for one (1) speed compression implant kit 20x20x20mm.This is report 1 of 1 for complaint (b)(4).
Additional 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.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 or Problem Description
The item was opened within theatre but the staple was dislodged from the handle.The item was disposed of as per hospital policy.No time added to the procedure.Patient details unavailable.
Additional 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, h4, h6: part number: se-2020, bme lot number: bse181020, manufacturing date or release to warehouse date: 13dec2018, place of manufacture: biomedical enterprises, san antonio, tx, lot expiration date: 13nov2023.Dhr review: no nonconformances were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.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.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.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: SPEED COMPRESSION IMPLANT KIT 20X20X20MM
• Common Device Name: BONE STAPLE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9452632
• Report Number: 8030965-2019-71037
• Device Sequence Number: 2158885
• Product Code: JDR
• UDI-Device Identifier: 00810633020227
• UDI-Public: (01)00810633020227
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K142292
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/26/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/13/2023
• Device Model Number: SE-2020
• Device Catalogue Number: SE-2020
• Device Lot Number: BSE181020
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/26/2019
• Supplement Date Received by Manufacturer: 12/17/2019; 02/13/2020
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 01/13/2020; 02/14/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - HANDLES: TRAUMA