MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH BME SPEED(TM) IMPLANT KIT 11 X 10 MM; STAPLE, FIXATION, BONE

Model Number	SE-1110
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	09/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.Part # se-1110.Synthes lot # bse181038.Supplier lot # 1807120256.Expiration date: november 26, 2023.Date of manufacture: january 3, 2019.Supplier: (b)(4).No ncr's 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 sub-components, which 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.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, during an open reduction internal fixation (orif) procedure that the staple released on its own.The surgeon did not press the button, which should have released the staple.There was no reported surgical delay.No fragments were generated.The procedure was completed successfully.There was no consequence to the patient.Concomitant devices reported: speed drill kit (part number bdk200042, lot bdk200042, quantity 1).This report involves one (1) bme speed(tm) implant kit 11 x 10 mm.This is report 1 of 1 for (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.H3, h4, h6 investigation summary product was not returned.Reviewing attached picture, the complaint condition of "dr donald states that he did not press the button to release the staple - rather it came off prematurely on its own accord" cannot be confirmed.The pictures received does not show a product at all.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
Updated: the procedure was able to be completed with the implant.Once it was inserted into the patient the device came off the inserter on its own.The surgeon was able to salvage it and press it into place with pressure.Concomitant devices reported: speed compression implant sizing guide (part #: sg-1, lot #: bsg180969, quantity: 1), speed drill kit (part #: dk-200, lot #: bdk200042, quantity: 1).

• Brand Name: BME SPEED(TM) IMPLANT KIT 11 X 10 MM
• Common Device Name: STAPLE, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10587447
• Report Number: 8030965-2020-07446
• Device Sequence Number: 11468693
• Product Code: JDR
• UDI-Device Identifier: 00810633020128
• UDI-Public: (01)00810633020128
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/26/2023
• Device Model Number: SE-1110
• Device Catalogue Number: SE-1110
• Device Lot Number: BSE181038
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/01/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 09/25/2020
• Supplement Report FDA Received Date: 10/28/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SPEED COMPRESSION IMPLANT SIZING GUIDE; SPEED DRILL KIT WITH 2.0MM DRILL BIT; SPEED DRILL KIT WITH 2.0MM DRILL BIT; SPEED DRILL KIT WITH 2.0MM DRILL BIT
• Patient Age: 13 YR