MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH BME SPEED(TM) IMPLANT KIT 13 X 10 MM; STAPLE, FIXATION, BONE

Model Number	SE-1310
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been 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 or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that during stock expiry date check it was noticed that the memory staple appears to have disengaged from it's insert while still in the packet.It can no longer be used in an operation.No patient involvement reported.This report is for one (1) bme speed(tm) implant kit 13 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.Investigation selection , investigation site: cq zuchwil , selected flow: labeling & packaging.Visual inspection: the returned implant is disengaged from it's insert while still in the unopened package.Otherwise there is no visible damage on its inside and outside.Drawing/specification review: the manufacturing review of the manufacturing documents shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.Summary: the complaint condition is confirmed as the implant is disengaged from it's insert while still in the unopened package.The root cause of the complaint condition could not be determined as the handling and use of the device are unknown.However, the condition of the complaint device is consistent with prior issues with the same occurrence.This is addressed with capa.Based on the investigation conducted, it has been determined that the most probable root cause for this type of complaint is the historical packaging design, with transit/handling being a contributing factor.Capa is open to address the design remediation of all bme product lines, which encompasses the design upgrade of speed from the current button inserters to slider inserters.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot part # se-1310, synthes lot # bse180482, supplier lot # 180112c893; 1804120061, expiration date: may 15, 2023 , date of manufacture: jun 28, 2018 , supplier: (b)(4), no ncr's were generated during production.Device history review 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.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: BME SPEED(TM) IMPLANT KIT 13 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: 10577023
• Report Number: 8030965-2020-07385
• Device Sequence Number: 16980454
• Product Code: JDR
• UDI-Device Identifier: 00810633020142
• UDI-Public: (01)00810633020142
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2020

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: 05/15/2023
• Device Model Number: SE-1310
• Device Catalogue Number: SE-1310
• Device Lot Number: BSE180482
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2020
• Initial Date Received by Manufacturer: 08/31/2020
• Supplement Date Received by Manufacturer: 10/26/2020
• Initial Report FDA Received Date: 09/23/2020
• Supplement Report FDA Received Date: 10/30/2020
• Patient Sequence Number: 1